Duration: 1 year
Location: Remote (US-based)
Brief Description:
The Director, Medical Safety (Scientist) is a key member of the Medical Safety team. This role provides leadership, line management, and mentorship for junior Medical Safety Scientists within Medical Safety organization. In close collaboration with Medical Safety Physician and/or Medical Safety Scientist group manager, this role leads, oversees and coordinates all Medical Safety activities for respective TA/ product franchise(s) across Medical Safety and broader organization, and contributes to regulatory submission safety strategy. These activities include but are not limited to:
signal management, 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., through leading Safety Management Teams, presenting at Executive Safety Board meetings), and SME support for HA inspections. 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 Medical Safety organization.
Essential Functions
· Manages and trains junior safety scientists in respective TA
· Leads cross-functional safety management teams (SMTs) and drives safety strategy for
responsible product/program.
· Drives signal management process using available methodologies, including making
recommendations for the assessment and prioritization of safety concerns.
· Ensures that processes and procedures are up to date to meet regulatory requirements and inspection readiness
· 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.
· Participate in and/or lead 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.
Required Knowledge, Skills, and Abilities
Minimum Requirements
· At least 8 years of experience in drug safety, including at least 5 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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