Associate Director, Pharmacovigilance Scientist

The Associate Director, Pharmacovigilance Scientist plays a critical role in safety data analyses for assigned investigational and/or marketed product(s) in partnership with the Safety Physician. This individual also serves as a subject matter expert for the PV Sciences group, contributing to strategic initiatives in collaboration with key stakeholders.

The Associate Director, Pharmacovigilance Scientist is expected to be equally effective in working collaboratively and independently. She/he will be responsible for leading and/or contributing to activities such as signal management, aggregate reports, RMP development, ad hoc safety query responses, literature surveillance, and safety analyses for regulatory submissions (NDA, MAA, etc.). For investigational products, this role may also encompass contributions to IB/RSIs, ICFs, SMPs, DMC materials, coding reviews, and safety analyses for CSRs, as applicable. The Associate Director, Pharmacovigilance Scientist will also contribute to process improvement initiatives, lead strategic innovations, and manage/mentor others, as opportunities permit.

Key Responsibilities

Serves as lead PV Scientist for assigned product(s) – 60%     

• Conducts signal detection, evaluation, and management, including data coordination, analysis, presentation, and documentation
• Leads and manages the planning, preparation, writing, and review of aggregate safety reports (DSURs, PADERs, PBRERs)
• Leads and manages the planning, preparation, writing, and review of risk management plans
• Performs literature surveillance
• Prepares materials for safety governance meetings
• Contributes to safety-related regulatory queries, including data coordination and analysis
• Contributes to relevant sections of key documents (IB/RSIs, CCDS/labels, ICF, DMC materials, coding reviews, CSRs, etc., as applicable)
• Contributes to safety analyses associated with regulatory filings (e.g., New Drug Applications or Marketing Authorization Applications)
• Supports team in proactively maintaining inspection readiness and serves as a subject matter expert in the event of an inspection

Other functional and cross-functional initiatives – 25%

• Leads strategic innovations (streamlines processes, evaluates implementation of new technology and resources, etc.)
• Conducts impact assessments (e.g., updates to regulations, etc.)
• Leads process improvement initiatives and consistency of cross-product processes
• Conducts functional trainings and shares knowledge with the team
• Supports deliverables for other products, where needed

Management and mentorship – 15%

• Manages, mentors, and trains junior members of the team
• Supports individual development of direct reports

Other duties and responsibilities as assigned