Purpose:
Describe the primary goals, objectives or functions or outputs of this position.
Serve independently as the Product Safety Team Lead for one or more assigned products in early development, with accountability for leading safety surveillance, signal detection, validation, assessment, and risk management activities.
Responsibilities:
List up to 10 main responsibilities for the job. Include information about accountability and scope.
- Serves independently as the Product Safety Team Lead for one or more assigned products in early development, providing medical and strategic leadership to the Product Safety Team and driving evidence-based safety decisions.
- Integrates pharmacology, chemistry, clinical data, and nonclinical toxicology to lead safety surveillance and inform product safety strategy.
- Provides safety oversight for pharmaceutical / biological / drug –device combined investigational products, contributes to the authorship of key pharmacovigilance documents, including but not limited to, development product safety assessments, regulatory responses and risk management plans
- Interprets and applies current regulatory guidance as appropriate for safety surveillance and authorship of PV documents
- Leads the analysis and interpretation of safety data and communicates conclusions and recommendations to cross-functional teams and governance bodies.
- Effectively writes, reviews and provides input on technical documents.
- Leads the strategy for Development Safety Update Reports (DSURs)
- Oversight of safety surveillance and pharmacovigilance activities for products in clinical trials
- Leads and implements the risk management strategy for assigned products
- Supports other Product Safety Team Leads and due diligence projects as needed
- Interprets applicable pharmacovigilance regulations to guide patient safety activities and cross-functional safety decision-making.