Job Description

Contact: Kevin Mednick

Phone: (215) 658-1379

Position Overview

Our client is a clinical-stage pharmaceutical company with a Research & Development innovation engine that aims to discover, develop and ultimately deliver impactful medicines to patients.

This role will lead the global safety strategy for our client’s small molecule pipeline, ensuring the highest standards of patient safety and regulatory compliance. This role will oversee all aspects of pharmacovigilance, risk management, and benefit-risk assessment across clinical development.

Key Responsibilities

Operational & Regulatory Compliance

• Lead the safety surveillance and signal detection process, ensuring timely identification and mitigation of safety risks.
• Oversee the preparation and submission of safety reports (e.g., DSURs, PSURs, RMPs, SUSARs, IND safety reports, 15-day alerts).
• Ensure robust case processing, signal evaluation, and risk management processes are in place.
• Represent the company in regulatory interactions regarding safety matters (FDA, EMA, etc.).

Cross-Functional Collaboration

• Work closely with Clinical Development, Clinical Operations, Regulatory, Medical Affairs, and Commercial teams to integrate safety considerations into decision-making.
• Partner with Regulatory Affairs to support new drug applications (NDAs) and marketing authorizations.
• Support DSMBs, advisory boards, and investigator meetings with safety expertise.

Team Leadership & Development

• Build and lead a high-performing pharmacovigilance team, fostering a culture of scientific excellence and compliance.
• Provide mentorship and guidance to internal safety professionals.

Key Requirements

• MD in a life sciences field required.
• 15+ years of pharmacovigilance experience in the biopharmaceutical industry, with 10+ years in leadership roles.
• Extensive experience in small molecule drug development (Phase 1-4).
• Proven track record of successful interactions with global health authorities on safety matters.
• Strong understanding of global PV regulations, GVP, and ICH guidelines.
• Demonstrated ability to lead safety risk management and benefit-risk assessments.
• Experience leading cross-functional safety teams and working in a fast-paced biotech environment.
• Expertise in clinical trial safety, post-marketing PV, and regulatory filings.
• Strong analytical, decision-making, and problem-solving skills.
• Excellent communication and stakeholder management abilities.
• Ability to thrive in a dynamic, high-growth biotech environment.

Location (Remote)

Location(S)

Boston, MA

If interested, please send a MS Word version of your resume to ***email_hidden***

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