Pharmacovigilance Scientist Resume Sample
Tyrel Goyette
8603 Bailey Corners,
Detroit,
MI
+1 (555) 232 4302
Work Experience
Senior Pharmacovigilance Scientist
06/2016
-
PRESENT
Los Angeles, CA
- Member of Safety Profiling Teams to ensure that case reports are accurately evaluated and databased, authoring or contributing to Product Specific Guidelines for assigned products
- Leads Aggregate Report management, including strategy, review and finalization of aggregate safety reports for assigned products, such as PSURs, DSURs, Pharmacovigilance Plans, Risk Evaluation and Mitigation Strategy Plans (REMS), and Risk Management Plans (RMPs)
- Key contributor to Safety Profiling Teams to ensure that case reports are accurately evaluated and databased, and authoring Product Specific Guidelines for assigned products
- Leads the signal management process (i.e., signal tracking, leading review meetings, etc.) for assigned product(s) and evaluates safety data and signals as part of ongoing pharmacovigilance activities. This includes synthesis of data from multiple sources and authoring signal evaluation reports
- Leads signaling review process and product Safety Signaling Team meetings
- Manages literature review for safety information
- Responsible for the SABR visualization tool for signal detection activities
- Leads the SABR visualization tool improvement process including working closely with the IT team, to fulfill all the requirements of visualization (training PV Scientists, collaborating with IT in resolving requests or questions from the PV scientist group)
- Serves as subject matter expert for signaling processes and systems
Pharmacovigilance Scientist
08/2010
-
05/2016
Dallas, TX
- Case series review or review of tabulated data
- Contributes to or develops Development Risk Management Plans and Risk Management Plansin the Compound Strategy Document or equivalent document, in collaboration with the GSOand the SSRM Center of Excellence for Risk Management
- Signal detection and data mining in collaboration with the GSO and the SSRM Center of Excellence for Signal Detection
- Overview of key safety information and draft summary of documents supporting responsesto Health Authorities and Affilitate queries, Ethics committees, revision of company coresafety data sheets; drafting of (sections of) and/or assisting GSO with Clinical Overviews,Summary of Clinical Safety, Investigator’s Brochures, etc
- Manage ongoing core signal detection activities for safety physician review; involves synthesis of data from multiple sources and critical thinking skills as well as authoring periodic signaling reports. Support the preparation and maintenance of safety sections of the Company Core Data Sheet
- Core member of the Safety Management Team, including setting agenda, producing necessary data outputs, preparing slide presentations, facilitating discussions & documenting conclusions
- Provide safety content for new drug applications and other regulatory filings including review of the safety and benefit risk sections, review and preparation of relevant safety sections to ensure consistency across documents and support response preparation
Senior Pharmacovigilance Scientist
04/2004
-
02/2010
New York, NY
- Collaborates with the safety physician in preparation and authoring developmental Risk Management Plans (DRMPs), safety sections of the EU Risk Management Plan (RMPs) and Risk Evaluation and Mitigation Strategy Plans (REMS)
- Supports safety related activities for clinical trials, including review of protocols, statistical analysis plans, safety content of Investigator Brochures and clinical study reports as well as perform aggregate safety data review
- Represents Pharmacovigilance on study teams, cross functional product teams, etc
- Supports proactive pharmacovigilance and risk management planning for designated products, including project managing preparation of the safety aspects of the global Risk Management Plans, in partnership with the Global Safety Physician (GSP) and (Senior/Principal) PV Scientist, as appropriate
- Provides patient safety input to pivotal study documents, for example Investigator Brochures, Protocols, Informed Consents and Clinical Study Reports
- Runs/supports routine signal detection processes in partnership with the GSP, for all products in area of responsibility
- Identifies and uses appropriate sources of information and database searches to retrieve relevant data for evaluation of signals. Creates first draft of documents with clear conclusions in response to internal or regulatory authority requests for safety data
- In consultation with the GSP and Clinical representatives, drafts the Reference Safety Information (RSI) for assigned development products; coordinates meetings and tracks timelines to ensure completion
- Provides patient safety input to the global regulatory submissions for new products, formulations or indications (e.g. NDA, BLA, MAA), in partnership with GSP and (Senior/Principal) PV Scientist and in liaison with other functional experts
Education
University of California, Santa Barbara
1998 - 2003
Science's Degree in Life Sciences Required
Professional Skills
- Strong relationship building skills, with ability to interact effectively in a multi-functional and multicultural team setting
- Excellent organization skills and ability to prioritize
- Demonstrated capabilities in: Project management, Time management, Presentation skills, Strong attention to detail and organization
- Excellent databases and coding skills including ability to perform advanced searches
- Experience of mentoring or supervising Patient Safety colleagues
- Relevant scientific experience and/or training discipline
- Drug Safety experience
How to write Pharmacovigilance Scientist Resume
Pharmacovigilance Scientist role is responsible for travel, software, training, database, trading, reporting, design, insurance, health, presentation.
To write great resume for pharmacovigilance scientist job, your resume must include:
- Your contact information
- Work experience
- Education
- Skill listing
Contact Information For Pharmacovigilance Scientist Resume
The section contact information is important in your pharmacovigilance scientist resume. The recruiter has to be able to contact you ASAP if they like to offer you the job. This is why you need to provide your:
- First and last name
- Telephone number
Work Experience in Your Pharmacovigilance Scientist Resume
The section work experience is an essential part of your pharmacovigilance scientist resume. It’s the one thing the recruiter really cares about and pays the most attention to.
This section, however, is not just a list of your previous pharmacovigilance scientist responsibilities. It's meant to present you as a wholesome candidate by showcasing your relevant accomplishments and should be tailored specifically to the particular pharmacovigilance scientist position you're applying to.
The work experience section should be the detailed summary of your latest 3 or 4 positions.
Representative Pharmacovigilance Scientist resume experience can include:
- Mentor less experienced scientists and teams
- Relevant Pharmaceutical Industry experience (drug safety / pharmacovigilance)
- Working knowledge of applicable global, regional, and local regulatory requirements (eg, ICH guidelines)
- Performs detailed vendor oversight activities including review of metrics, and deliverables from vendor
- Support Medical Safety Assessment Physicians (MSAP) in leading Safety Data Review (SDR) Teams
- Raises appropriate concerns/issues to senior staff in a timely manner
Education on a Pharmacovigilance Scientist Resume
Make sure to make education a priority on your pharmacovigilance scientist resume. If you’ve been working for a few years and have a few solid positions to show, put your education after your pharmacovigilance scientist experience. For example, if you have a Ph.D in Neuroscience and a Master's in the same sphere, just list your Ph.D. Besides the doctorate, Master’s degrees go next, followed by Bachelor’s and finally, Associate’s degree.
Additional details to include:
- School you graduated from
- Major/ minor
- Year of graduation
- Location of school
These are the four additional pieces of information you should mention when listing your education on your resume.
Professional Skills in Pharmacovigilance Scientist Resume
When listing skills on your pharmacovigilance scientist resume, remember always to be honest about your level of ability. Include the Skills section after experience.
Present the most important skills in your resume, there's a list of typical pharmacovigilance scientist skills:
- Excellent written and verbal communication skills, strong presentation skills, and good negotiating and influencing skills
- Proven good communication skills with ability to work across cultures
- Biotech/pharmaceutical industry experience, including at least 2 year of experience in clinical safety / Pharmacovigilance
- Strong experience in pharmacovigilance writing and review of aggregate reports, responses to questions, narratives, follow-up requests
- Contribute to the assessment of clinical trial vendors for outsourcing projects and communicates business needs effectively to PV management
- Experience using Microsoft Word templates
List of Typical Experience For a Pharmacovigilance Scientist Resume
1
Experience For Senior Pharmacovigilance Scientist Resume
- Training of task or process-related activities
- Participate in department training
- Review study protocols, statistical analysis plans, and other clinical study-related documents
- Review standard design of tables, figures and listings for safety data from clinical studies
- Develop Safety Management Plans for Clinical Trial programs
2
Experience For Principal Pharmacovigilance Scientist Resume
- Reviews, documents, and escalates concerns and issues to PV management
- Reports to R&D Global Regulatory and Safety Services
- Tasked with Global Pharmacovigilance and Epidemiology (GPV&E)
- Support Medical Safety Assessment Physicians (MSAP)
- Lead Safety Data Review (SDR) Teams
- Perform core signal detection activities, elevate program or portfolio issues
3
Experience For Pharmacovigilance Scientist Phd-research & Development Resume
- Author safety data query responses
- Contribute to specified sections of the Periodic Benefit Risk Update Report (PBRER) and Development Safety Update Report
- Perform core signal detection activities
- Ensure pharmacovigilance regulatory compliance
- Attend departmental meetings and trainings
- Participate in department and/or cross-functional initiatives
4
Experience For Pharmacovigilance Scientist Development Team Lead Resume
- Appropriately perform core signal detection activities, elevate program or portfolio issues
- Ensure pharmacovigilance regulatory compliance with oversight, as needed
- Or 1 to 3 years = MS/PharmD/PhD/MD, or equivalent
- Working understanding of medical concepts and some familiarity with safety activities in drug development, drug post marketing and global safety health authority requirements
- Computer Savy - MS Word, Excel and PowerPoint
- Intermediate knowledge of PV regulations
- Support coordination and project management of periodic safety reports (e.g., PSUR/PBRER, PADER, DSUR, etc) in accordance with Kite SOPs and regulatory requirements
5
Experience For Pharmacovigilance Scientist Lead Resume
- Support and facilitate cross-functional meetings relating to risk management
- Support preparation and maintenance of Risk Management plans and REMS
- Serve as Safety Lead for one more Kite clinical programs
- Direct Pharmacovigilance Safety Science is required
- Ensure timely, quality deliverables for assigned tasks related to core deliverables with oversight as appropriate
- Collaborate with PVER team members to perform assigned tasks, Interact with other stakeholders (e.g Safety Surveillance Physician (SSP), Medical Safety Officer (MSO)) on relevant deliverables
6
Experience For Pharmacovigilance Scientist Resume
- Author/contribute to the preparation of core safety deliverables
- Ensure commitments (e.g., Pharmacovigilance Agreements (PVAs), assessment reports) are met as appropriate for assigned tasks
- Participate in department initiatives as appropriate
- High integrity, sense of urgency, ability to recognize time sensitivity, willingness to work in a matrix environment, willingness to work independently and with team members in different locations and time zones
- Knowledge and understanding of safety database search strategies to support the Pharmacovigilance Physician in the identification and evaluation of safety signals
- Experience in Argus safety database
7
Experience For Senior Pharmacovigilance Scientist Resume
- MARKETING ANALYSIS MITIGATION
- Governance Board Interactions
- Focus on delivering excellent results and improving the performance of oneself and of Ironwood by taking initiative to try new approaches, while still following the rules (e.g., company, government and ethical), by taking action to surpass one’s own past performance, excel at an objective measure or goal, or do something that has never been done before
List of Typical Skills For a Pharmacovigilance Scientist Resume
1
Skills For Senior Pharmacovigilance Scientist Resume
- Express ideas and information clearly and accurately. Excellent interpersonal, communication, and personal organization skills
- Good understanding of epidemiologic data
- Experience in developing case series retrieval strategies
- Experience in pharmacovigilance writing and review of aggregate reports, responses to questions, narratives, follow-up requests
- Experience with MedDRA coding and safety database systems
- Knowledge and experience with safety surveillance, signal detection, labeling analyses, and ad hoc safety analyses
- Relevant pharmacovigilance experience
- Hands-on experience in case processing of clinical trial SAE cases and preparation of AOSE
- Strong working knowledge of applicable regulations and international guidelines
2
Skills For Principal Pharmacovigilance Scientist Resume
- Experience in the review of relevant safety information from all sources and analysis of safety data
- Provides training and mentoring of Patient Safety Coordinators on local and global adverse event reporting and with respect to career development
- Assumes a lead role in identifying Patient Safety related issues and is instrumental in implementing solutions to those issues
- Basic understanding of data mining in the evaluation of safety signals
- Support tracking and management of potential/confirmed signals according to Kite SOPs and guidelines
3
Skills For Pharmacovigilance Scientist Phd-research & Development Resume
- Estimated 5-10 times per year including possible international travel
- Perform reconciliation with licensing partners and CROs to ensure compliance and accurate receipt of all adverse event information
- Able to influence whilst maintaining independent and objective views
- A comprehensive understanding of how their role within the function contributes to the overall business
- Basic knowledge of common data processing software (i.e., Excel, PowerPoint, Word) and database systems
- Works as a team player and supports the development of other team members
- Assumes a lead role in supporting the business unit needs and Patient Safety by actively developing and maintaining partnerships with internal and external customers
4
Skills For Pharmacovigilance Scientist Development Team Lead Resume
- Assumes a lead role in the interview process for prospective new team members
- Assemble information, date stamp, image source documents, create paper and/or electronic folders, associate electronic/paper information to electronic/paper folder as appropriate
- Verify the presence of all information required to be a case (product, reporter, event, and patient), and request critical missing information for non-cases by expeditiously contacting the reporter. Identify duplicates and non-cases
- Incorporate physician input, append case files and perform in-process quality review for case receipt
- Update the safety database with the submission date
5
Skills For Pharmacovigilance Scientist Lead Resume
- Generate and work with other team members to send a follow-up letter/queries to the appropriate reporter using the most expedient mechanism, forwarding to clinical sites where appropriate
- Identify database cases eligible for archiving
- Assist with the imaging of case information to ensure all documents are scanned and archived appropriately in compliance with internal standards and regulatory guidelines
- Adhere to CAPAs from the Quality, Training and Compliance (QTC) group
- Identify clinically relevant information missing from case report and facilitate its collection (in consultation with medical staff as required) by preparing follow-up request as needed
- Responsible for supporting ICSR Team Manager and Senior PV Scientists with improvements and /or remediation’s to processes and procedures as applicable
6
Skills For Pharmacovigilance Scientist Resume
- Advanced knowledge of PV regulations
- MSc/PhD in related Scientific Discipline
- Strategic Leadership (identifies untapped opportunities)
- Acts Decisively (create clarity for others to act decisively)
- The attainment of advanced compound expertise might, for exceptional individuals, allow for Global Safety Lead (GSL) responsibilities where the individual has demonstrated both the requisite depth of knowledge and associated advanced communication skills
- Accountable for activities supporting the ICSR process including Quality Review, Blind breaks, Logical and Physical Deletions
- Responsible for providing leadership to the ICSR Teams, including delegation of workload and the co-ordination of issues/projects across PD Safety Operations
- Responsible for providing expert case processing and molecule related guidance to ICSR Team and other stakeholders, and acting as a Subject Matter Expert for your assigned processes
7
Skills For Senior Pharmacovigilance Scientist Resume
- Experience with coding according to the Medical Dictionary for Regulatory Activities (MedDRA)
- In depth knowledge of global clinical and post marketing safety regulations, guidances, and reporting processes
- Responsible for supporting the efficient management of ICSR Team resources
- Responsible for supporting ICSR Team Manager with improvements to processes
- Responsible for liaising regularly with ICSR Team Manager to ensure awareness of workload, issues and other relevant information
- Responsible for maintaining up to date knowledge in order to be able to advise others on safety and pharmacovigilance-related topics as needed
8
Skills For Principal Pharmacovigilance Scientist Resume
- Responsible for engaging with stakeholders within and outside PD Safety Operations
- Awareness of applicable regulations and guidances related to post-marketing aggregate safety requirements
- In depth understanding of medical terminology
- Project management of safety/regulatory documents
- Pharmaceutical and/or biotechnology industry or relevant service provider experience, including experience in preparing clinical trial safety management plans and aggregate reports
- Experience with development, authorship and review of aggregate reports (i.e., PSUR, DSUR, IND annual, NDA annual, etc.), Risk Management Plans, and Risk Evaluation and Mitigation Strategies
- Ideally looking for a combination of experience including experience in aggregate safety reports and safety signal management. Strong background in clinical trial drug safety is required
- Clinical and post-marketing safety experience from pharmaceutical and/or biotechnology industry or relevant service provider
- Experience with review of search results from scientific literature databases
9
Skills For Pharmacovigilance Scientist Phd-research & Development Resume
- Strong background in clinical trial drug safety is required
- Strong knowledge of safety database (preferably ARGUS), MedDRA, and WHO Drug
- Direct Pharmacovigilance Safety Science is required
- Basic awareness of Pharmacovigilance regulations
- Leverage a deep understanding of oneself through knowing one’s strengths and weaknesses, proactively asking for feedback to balance self-perception, and being resilient in order to increase one’s effectiveness
- Recognize opportunities and/or issues and applying analytical and creative thinking to maximize performance
- Work cooperatively with colleagues and take initiatives to build relationships despite differences in interest, offering support and help to peers without being asked or proactively seeking input from others to solve problems
10
Skills For Pharmacovigilance Scientist Development Team Lead Resume
- Targeting one’s efforts on discovering and meeting an internal or external customer’s needs by ensuring timely follow through to customer inquiries or business issues, and being proactive in adding value to the customer
- Clinical Development (Early and/or Late Phase)
- Risk Management Plans (from scratch)
- Work with Novartis country safety departments, Clinical Safety Scientists and Pharmacovigilance Leaders to ensure that reports are accurately collected, evaluated and databased
- Work collaboratively with PV Physicians in all pharmacovigilance-related activities
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