Director, Medical Safety (Scientist)

Role Summary

The Director, Medical Safety (Scientist) is a key member of the Medical Safety team, providing leadership, line management, and mentorship for junior safety scientists. Working with Medical Safety Physicians and line managers, this role leads and coordinates all Medical Safety activities for the assigned therapeutic area/product franchise and the Medical Safety organization. It ensures up-to-date processes for safety governance, signal management, clinical surveillance, periodic safety reporting, and risk management, and contributes to regulatory safety strategy.

Responsibilities

• 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 prioritization of safety concerns.
• Effectively communicates with the interdisciplinary team regarding ongoing signal evaluation.
• Ensures safety information is evaluated to meet internal and external requirements, including labeling updates; produces evaluation documents with clear conclusions.
• Leads the coordination of aggregate safety reports (PBRERs, DSURs, PADERs) and authors relevant sections as appropriate.
• Authors or provides guidance for 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.

Qualifications

• Required Knowledge, Skills, and Abilities: 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; expert knowledge of pharmacovigilance regulations regarding aggregate safety reports, risk management plans, and signal management; excellent medical writing skills and proven ability to 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 ability to learn new programs/databases.
• Education & Licenses: 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.

Education

• 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.

Physical Demands

• Occasional mobility within office environment.
• Routinely sitting for extended periods of time.
• Constantly operating a computer, printer, telephone and other similar office machinery.

Work Environment

• Work indoors in a normal office environment with little exposure to excessive noise, dust, fumes, vibrations and temperature changes.
• Frequent computer use at workstation.
• May move from one work location to another occasionally.
• Responsibilities may require a work schedule that may include working outside of “normal” work hours, to meet business demands.
• Occasional public contact requiring appropriate business apparel.