Contact: Kevin Mednick
Phone: (215) 658-1379

Position Overview

Our client is a is a clinical stage biotechnology company advancing clinical development of novel therapeutic candidates for autoimmune and inflammatory diseases with significant unmet medical need.

The Vice President Drug Safety will lead the global strategy and execution of all safety surveillance, risk management, and regulatory compliance activities across the product lifecycle from clinical development through post-marketing

Key Responsibilities:

Define and implement our client’s global pharmacovigilance and drug safety strategy, chairing the safety committee and ensuring alignment with corporate priorities and clinical development objectives.
Design, build, and continuously evolve a scalable pharmacovigilance operating model, including safety surveillance systems, processes, and SOPs appropriate to our client’s stage of growth.
As our client grows, establish and maintain global safety reporting infrastructure, ensuring timely, accurate, and compliant adverse event reporting across all applicable regions.
Oversee and maintain end to end safety operations, including case intake and processing, signal detection, aggregate reporting, and lifecycle risk management activities to include attendance at monthly CRO safety reviews.
Lead the development and execution of risk management plans and safety communication strategies across clinical programs.
Ensure and sustain inspection readiness, quality oversight, and continuous process improvement across all pharmacovigilance and drug safety activities.
Serve as the primary senior safety authority, providing strategic guidance and safety leadership to executive leadership and cross functional teams.
Represent our client in regulatory interactions related to safety, including engagement with global health authorities and responses to safety related inquiries.
Establish and oversee vendor and partner governance, ensuring high-quality delivery, accountability, and compliance across outsourced pharmacovigilance activities.
As our client grows, scale the safety group by recruiting, leading, mentoring, and developing a high performing pharmacovigilance and drug safety organization, setting clear expectations for quality, rigor, and professional growth.
Define and embed departmental standards for safety excellence, governance, and professional development across the Pharmacovigilance function.
Define and own the safety analysis strategy for interventional and non interventional studies, as well as post-marketing activities, ensuring alignment with ICH E3/E9, E2A/E2F, FDA/EMA expectations, and company standards.
Author or provide authoritative input into the Safety Analysis Plan (SAP): Specify, review, and approve all safety-related Tables, Figures, and Listings (TFLs)
Ensure SAP alignment with DSUR and IB safety narratives to maintain consistency across regulatory documents and public disclosures.
Support medical review and interpretation of safety TFLs for: Interim analyses (e.g. DMC/IDMC reviews), topline and press release enabling readouts, and final CSR database locks.

Key Requirements:

Advanced degree required: MD, PharmD, PhD or equivalent.
10+ years of progressive experience in pharmacovigilance, drug safety, clinical safety, with 5+ years of experience with direct oversight of PV/drug safety team.
Demonstrated leadership experience with accountability for global safety strategy, operations, and regulatory compliance.
Deep expertise in global pharmacovigilance regulations, safety reporting requirements, and risk management frameworks.
Strong understanding of safety databases and tools, including ARGUS.
Comfort in working in a fast-paced, matrixed environment and building and growing teams and systems.
Effective communicator with strong verbal and written skills.
Experience in immunology, autoimmune, inflammatory, or rare diseases.
Experience managing all aspects of post-marketing product safety in US, EU, and other major territories
Direct knowledge and experience with major filings including IND, CTA, NDA/BLA, and MAAs, including broad experience representing and articulating benefit-risk assessments to Regulatory Agencies.
Line management experience.

Location: Remote

Location(s)

Boston, MA

If interested, please send a MS Word version of your resume to [email protected]

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