Senior Safety Scientist Job Description
The Senior Safety Scientist role is a key focus on drug safety, evaluation, and risk-management. The successful candidate will lead the safety scientists in developing signal detection practices and provide leadership for both the Global Drug Safety Platform (GDSP) group and external departments regarding signal detection, signal evaluation, and risk management.
Responsibilities include monitoring and evaluating safety profiles for allocated products, coordination and administration of the signal detection team, and supporting documentation. The Sr. Safety Scientist will focus on post-marketing data but will include clinical development molecules as required.
Main Responsibilities:
* Develop fit-for-purpose and appropriate signal detection strategies for assigned products utilizing various techniques and detection thresholds based on molecule characteristics.
* Partner with the assigned product Medical Director GDSP to ensure accurate and compliant safety documentation.
* Develop and maintain an understanding of the safety profile of assigned product(s) and understand the indication disease background and epidemiology.
* Lead the preparation and authoring of aggregate safety reports for assigned products, such as Periodic Safety Update Reports (PSURs), Periodic Benefit-Risk Evaluation Reports (PBRERs), Development Safety Update Reports (DSURs), Pharmacovigilance Plans, and Risk Management strategy and Plans.
* Facilitate signal management processes for assigned products and evaluate safety data and signals as part of ongoing pharmacovigilance activities.
* Author signal evaluation reports (SERs) or sections of SERs, and review SERs written by more junior safety scientists.
* Review clinical protocols and study reports to ensure safety risk is adequately addressed.
* Contribute to the safety section of the Investigators Brochure (IB).
* Contribute to regulatory authority submissions (New Drug Applications (NDAs), Marketing Authorization Applications (MAAs), Variations) by reviewing safety data and preparing relevant sections of the submission.
Requirements:
* Lifescience degree such as PhD in scientific field, pharmacy degree, MS or BS in scientific field, MPH, BS Nursing.
* Minimum of 6 years in pharmacovigilance in a pharmaceutical or biotech environment required, with a thorough understanding of signal detection and assessment.
* Expert knowledge of FDA safety regulations, EMA safety regulation, GVP, ICH Guidelines, and other applicable regulatory guidance documents.
* Expertise in global pharmacovigilance regulations, clinical safety assessments, safety signal detection, and risk management, including interactions with regulatory authorities.
* Strong understanding of epidemiologic principles and global pharmacovigilance regulations.
* Strong organizational skills, timeline management, and ability to work in matrixed teams.