Senior/Executive Director, Global Head of Medical Safety

Our client is a clinical stage biotechnology company. They have asked us to assist them in their search for a Senior / Executive Director, Global Head of Medical Safety.

Major tasks and responsibilities include :

• Monitors the benefit-risk profile of assigned compounds in an ongoing fashion and in accordance with Company and Pharmacovigilance processes.
• Supports and leads PV risk management processes including PV Status and Safety Review Team meetings.
• Identifies and analyzes clinical safety signals.
• Performs ongoing reviews of emerging safety data from various sources including published literature.
• Ensures appropriate clinical safety risk communication and escalation within Company.
• Oversees the PV vendor and continuously maintains and improves effective systems to fulfill the requirements for signal detection and aggregate report compilation.
• Produces high quality aggregate reports and responses to regulatory queries.
• Provides strategic and proactive safety input into development plans.
• Ensures adequate labeling of safety related information.
• Establishes the Safety Epidemiology function within PV.
• Represents safety and PV in cross-functional submission teams.
• Ensures generation, consistency, and quality of safety sections in submission documents.
• Updates safety-related portions of Investigator’s Brochures.
• Participates in and drives safety agreement development and review processes.
• Manages the effective and timely delivery of : aggregate reports including Periodic Safety Update Reports / Periodic Benefit Risk Evaluation Reports (PSUR / PBRERs), Development Safety Update Reports (DSURs), Development Risk Management Plans (DRMPs) and Risk Management Plans (RMPs) (core and European Union (EU), Benefit Risk Statements, Safety section of Core Datasheets, answers to assigned safety relevant Health Authority (HA) requests and complex Answer to Query (A2Q), Safety relevant communications such as Dear Health Care Provider (DHCP) letters.
• Ensures expert safety review and leadership of critical development program documents including protocols, ICFs, IBs, IMPDs, CSRs, INDs, CTAs, and NDA / MAA submissions (including RMPs and REMs).
• Serves as the Company’s Subject Matter Expert for all strategic safety related material including providing leadership and guidance for all relevant regulatory authority safety related questions, audits, and inspections.

We seek candidates with the following qualifications :

• An MD or MBBS is required with a minimum of seven years of pharmacovigilance experience within the pharmaceutical or biotechnology industry.
• Must have appropriate experience with Regulatory Agency interactions.
• Good knowledge of pharmacovigilance relevant regulations is required.
• Must have proven evidence of effective delivery of high-quality safety relevant documents.
• Requires experience with NDA / MAA submissions (including RMPs and REMs).
• Experience with PV vendor assessment and oversight is required.
• Must have knowledge of relevant concepts in data management and systems, pharmacoepidemiology and statistics.
• Must be able to effectively communicates in written and spoken English.
• Requires the ability to communicate complex issues in an understandable, effective, and relevant manner.
• Strong influencing skills with the ability to explain and defend a position in the face of opposition are required.
• Requires a focus to activities and planning, with proactive planning and prioritization skills.
• Must be able to take ownership of appropriate issues and appropriately delegates.
• Technical expertise in pharmacovigilance and clinical safety.

If interested, please apply directly to this job posting. No calls please. Include your daytime phone number and we will contact you confidentially or reply to your email.

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