Senior PV Scientist
Vor 3 Tagen
Senior PV Scientist serves as a global product lead for Pharmacovigilance activities within the Safety department including managing PV Scientist(s) assigned to products within the Senior PV Scientist's designated products.
Key Responsibilities:
- Leads the signal management process (i.e., signal detection, signal tracking, signal documentation, facilitating decisions regarding signals and safety risk, etc.) for assigned product(s) and evaluates safety data and signals as part of ongoing pharmacovigilance activities. Includes synthesis of data from multiple sources and authoring signal evaluation reports.
- Leads signaling review process and product Safety Signaling Team meetings.
- Provides safety leadership to cross functional project meetings.
- Leads process for responding to safety questions from regulatory authorities.
- Provides strategic input to the authoring of regulatory documents such as PSURs, DSURs, PADERs, Addendum to Clinical Overview.
- Leads development of Pharmacovigilance Plans, Risk Evaluation and Mitigation Strategy Plans (REMS), and Risk Management Plans (RMPs) including providing safety input to post authorization safety studies (PASS) and additional risk minimization measures.
- Leads development of the strategy for medical and scientific literature review for safety information.
- Provides safety leadership to regulatory submissions in collaboration with the Global Safety Officer.
- Maintains an up to date understanding of relevant global safety regulations and guidelines.
- Collaborates with Global Safety Officers and other Safety MDs for assigned investigational programs including clinical trial activities (protocol review, ICF review, etc.), safety committee management, data analysis, signal detection, ad hoc requests and other product activities, as assigned.
- Leads initiatives for process improvement and consistency regarding aggregate reporting, clinical trial safety oversight, signal management and responding to ad hoc safety questions.
- Direct supervision of PV Scientist(s) including hiring, training and mentoring.
A typical day might include:
- Working on a post-marketing and/or investigational product to ensure products in clinical trials continue to maintain good standing with countries where studies are ongoing, to ensure clinical studies are completed, and for marketed products, ensures the marketing authorization remains in good standing.
- Setting response strategy and authoring safety related health authority requests.
- Performing routine signal detection and safety surveillance activities.
- Reviewing key safety documents such as reference safety information, aggregate reports, risk management plans etc., to ensure they meet the required standards.
- Working cross functionally to deliver process improvement initiatives.
- Working on safety science related activities (e.g. signal detection/automation methodology, pharmacovigilance research, exploring new data sources such as RWD).
Essential Skills and Qualifications Required:
- Understands, interprets, analyzes, and clearly presents scientific and medical data in verbal and written format (including intermediate understanding and application of medical concepts and terminology).
- Strong pharmacovigilance and drug development foundation, including knowledge of applicable clinical trial safety regulations and post-marketing safety regulations. Includes knowledge of case processing, expedited reporting rules, and safety database concepts.
- Ability to work with complex clinical data to produce robust assessments of safety data. A familiarity of pharmacoepidemiology definitions and their use in pharmacovigilance is desirable for working with safety science research activities.
- Knowledge of common data processing software (EXCEL, PowerPoint, Microsoft Word, Business Objects). Knowledge of common safety database systems.
- Demonstrates leadership and interacts collaboratively and effectively in a team environment (including Safety, Clinical Development, Medical Affairs, Clinical Operations, and Regulatory), as well as with external colleagues.
- Strong organizational skills, including the ability to prioritize independently with minimal supervision.
Education and Experience Requirements for Job:
Bachelor's Degree or MSc in biologic or natural science; or health care discipline. Advanced degree (PhD, MPH, NP, PharmD, etc.) required.
Minimum 7 years Pharmacovigilance experience, including experience in safety signal management and aggregate safety reports. Prior management of direct reports preferred.
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