Director, Medical Safety; Scientist

Role Summary

The Director, Medical Safety (Scientist) leads the Medical Safety team, provides leadership and mentorship for junior safety scientists, and coordinates Medical Safety activities across the respective therapeutic area/product franchise as well as the organization. Responsibilities include ensuring up-to-date processes for safety governance, signal management, clinical surveillance, periodic safety reporting, and risk management, with involvement in regulatory submission safety strategy. The role also contributes to safety strategy, leads safety governance initiatives, and represents Medical Safety in global leadership settings.

• Leads cross-functional safety management teams (SMTs) and drives safety strategy for the responsible product/program.
• Ensures processes and procedures are up to date to meet regulatory requirements and inspection readiness.
• Drives signal management process using available methodologies, including recommendations for assessment and prioritization of safety concerns.
• Effectively communicates with the interdisciplinary team regarding ongoing signal evaluation.
• Evaluates safety information to meet internal and external requirements, including identifying labeling update needs; produces evaluation documents with clear conclusions.
• Leads coordination of aggregate safety reports (PBRERs, DSURs, PADERs) and authors relevant sections as appropriate.
• Authors or guides the production of risk management plans (RMPs).
• Provides strategic input into regulatory requests/responses.
• Delivers clinical safety input into the clinical development program.
• Leads the medical safety contributions of global regulatory submissions for new products, formulations or indications.
• Participates in and/or leads internal safety surveillance meetings and joint safety meetings with licensing partners as needed.
• Provides medical safety input into creation/review of Safety Data Exchange Agreements and/or other PV agreements.
• Escalates issues/concerns to senior management in a timely and appropriate manner.
• Mentors and trains junior members of the Medical Safety team.

• At least 8 years of experience in drug safety, including at least 5 years in surveillance/risk management.
• Ability to independently search clinical safety and literature databases for relevant information.
• Expert knowledge of pharmacovigilance regulations regarding aggregate safety reports, risk management plans, and signal management.
• Excellent medical writing skills and proven ability to effectively lead interdisciplinary teams.
• In-depth knowledge of medical and drug terminology, and the clinical development process.
• Familiarity with MedDRA and safety databases; proficient with Windows applications and able to learn new programs/databases.

• Requires a degree (e.g., BS, BA, MSc or PhD) or professional qualification in a life science field (e.g., nursing or pharmacy) or a relevant scientific/technical discipline.

• Occasional mobility within office environment; routine sitting for extended periods; frequent computer use; may require working outside normal hours to meet business demands.
• Work indoors in an office environment with typical conditions; may move between work locations occasionally; occasional public contact requiring appropriate business apparel.