Overview
The Associate Director, Medical Safety (Scientist) is a key member of the Medical Safety team. This role is responsible for ensuring up-to-date processes and procedures for safety governance, signal management, clinical surveillance, periodic safety reporting, and risk management and/or driving innovation initiatives within the Medical Safety organization. In close collaboration with the Medical Safety Physician and/or Medical Safety Scientist line manager, this role contributes to regulatory submission safety strategy.
Responsibilities
* Leads cross-functional safety management teams (SMTs) and drives safety strategy for the responsible product/program.
* Ensures that processes and procedures are up to date to meet regulatory requirements and inspection readiness.
* Drives signal management process using available methodologies, including making recommendations for the assessment and prioritization of safety concerns.
* Effectively communicates with members of the interdisciplinary team regarding ongoing signal evaluation.
* Ensures that available safety information is evaluated to meet internal and external requirements, including identifying the need for labeling updates. Produces accurate and fit-for-purpose evaluation documents with clear conclusions, as required.
* 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 as well as 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.
Qualifications
* At least 6 years of experience in drug safety, including at least 4 years of experience 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, as well as proven ability to effectively lead interdisciplinary teams.
* In-depth knowledge of medical and drug terminology, as well as the clinical development process.
* Familiarity with MedDRA and safety databases; proficient with Windows applications, and ability to learn new programs/databases.
Education and 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 and experience.
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