Director, Safety Scientist, Pharmacovigilance

What You’ll Do

The Safety Scientist will be responsible for high quality safety surveillance activities including medical review of individual case safety reports (ICSRs), aggregate report production, safety governance meeting coordination, safety signal detection and assessment, and safety risk management activities for assigned products. This individual will collaborate with Program Safety Lead and other program team members, pharmacovigilance operations, and CROs to ensure proactive safety surveillance in compliance with global regulations.

Responsibilities

• Manage safety surveillance and signal detection activities (period review of aggregate safety data, safety surveillance team meetings, track signals and related documentation)
• Represent PV at clinical study team for assigned product
• Develop signal assessment report under the oversight of Program safety lead for validated safety signal
• Collaborate with PV operations for timely and accurate medical review of ICSRs for assigned clinical study as needed
• Develop and contribute safety risk management plan across product lifecycle
• Develop and manage periodic reports (DSUR/PBRER)
• Contribute for data analysis and authoring of safety sections for regulatory submissions and regulatory responses
• Contribute for the development or updates of safety surveillance and risk management SOPs, templates etc.
• Collaborate with clinical study teams on safety surveillance deliverables (IB, RSI, Protocol, Briefing documents etc.)
• Participating in PV audit and inspections
• Represent Pharmacovigilance function in committees and activities both internally and externally when appropriate.

Qualifications

• Health care professional degree (e.g. RN, BSN, PharmD) or advanced degree (Masters/PhD) in biomedical sciences, pharmaceutical sciences, or related life science.
  • Preferred: Post-graduate training in epidemiology (e.g. MPH)
• Minimum 10 years of pharmacovigilance experience within the biopharmaceutical industry with at least 3 years of direct clinical/patient care experience
  • Preferred: Safety surveillance and risk management experience in neuroscience, psychiatry or neurodegenerative disease area
• Competence in conducting safety data reviews, preparation of aggregate reports, signal detection and risk management plans for investigational and/or post-marketed products
• Experience with MedDRA and drug coding reviews
• Demonstrated expertise in global PV regulations, GVP and ICH guidelines, safety systems, and drug development processes
• Experience in PV processes for individual case handling, signal management, aggregate data review, aggregate reports, and audits/inspections
• Exceptional communication and cross-functional collaboration skills