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 / 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 is also responsible for contributing to regulatory submission safety strategy. Other responsibilities include but are not limited to: signal management activities, production of aggregate safety reports (e.g., DSURs, PADERs, PBRERs), provision of high-level scientific expertise in the safety evaluation and risk management strategies of assigned products (e.g., signal evaluation reports, health hazard evaluations, and RMPs), global leadership / representation of Medical Safety within the company (e.g., leading Safety Management Teams, presenting at Executive Safety Board meetings), and SME support for HA inspections.
Essential Functions
* Leads cross-functional safety management teams (SMTs) and drives safety strategy for 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 in order to meet both 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 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.
* Mentors and trains junior members of the Medical Safety team.
Required Knowledge, Skills, and Abilities
Minimum Requirements
* 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.
Required/Preferred 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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