Job Description

Confidential Company

This is an exciting time to join a fast-growing, clinical-stage biotechnology company advancing the frontiers of mast cell biology. With a robust pipeline of antibody-based therapeutics, this innovative biotech is developing transformative treatments for patients suffering from severe inflammatory, allergic, autoimmune, and other debilitating diseases. Backed by deep scientific expertise and strong in-house capabilities, the company is uniquely positioned to deliver novel therapies that engage the immune system and modulate critical disease pathways.

Purpose of the Position

The Head of Pharmacovigilance and Risk Management provides strategic leadership and tactical oversight of the clinical safety department. Serves as subject matter expert for all medical and safety needs. Oversees submission for safety reports, interacts with regulatory authorities, monitors safety across all programs. Reports to the CMO. This role will require onsite presence in Hampton, NJ or New Haven, CT offices.

Key Responsibilities

• Global management of departmental operations (resourcing, operating procedures, training, technology, budget, etc.).
• Maintains currency with global regulations and guidance related to safety surveillance and reporting; serves as expert resource within the organization regarding interpretation and implementation.
• Ensures practices and infrastructure to support all safety surveillance activities including but not limited to individual case processing/evaluation and signal detection through aggregate safety data medical review; directly participates in these activities as needed.
• Leads the continuing evolution and improvement of practices to ensure timely identification, evaluation and management of safety risks throughout the product life-cycle.
• Utilizes scientific/clinical expertise to interpret, synthesize and communicate complex safety information; contribute to the development of benefit/risk assessments, aggregate data reports, safety-related submissions/responses to health authorities, etc.
• Routinely liaises with applicable functional areas (Clinical Science and Operations, Regulatory Affairs, Biostatistics, Medical Affairs) on drug safety related matters.

The Candidate

• Experience and Professional Qualifications
• Thorough understanding of the drug development process and safety surveillance activities, gained through significant experience (at least 8-10 years) in the clinical research industry.
• In-depth knowledge of global regulations and standard industry practices for management of pre and post-marketing drug safety.
• Proven leadership ability with experience recruiting and managing pharmacovigilance personnel.
• MD required, specialty and or experience managing drug safety in immunology/inflammation indications desirable
• Team Player, ability to manage by influence
• Excellent oral and written communication skills.
• Ability to work in fast-paced small company environment.

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