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Reporting to the Chief Development Officer, the VP, Drug Safety & Pharmacovigilance will be responsible for leading the overall strategic direction for Safety and Pharmacovigilance and, through leadership of the team, oversee the operational delivery of safety and pharmacovigilance activities at Bicycle.
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Our team is changing, and we are building a global team passionate about patient safety in the drug development process. The Hepatic Clinical Safety Knowledge Group (SKG) Lead manages a diverse range of activities related to monitoring, diagnosis, and mitigation of drug/biological-induced organ toxicity in a matrix environment.
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This role is pivotal in ensuring that Merus remains a leader in patient safety and pharmacovigilance, fostering a culture where safety is integrated into every aspect of our drug development process.
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Provide strategic planning, implementation, and management of drug safety activities to support clinical development of company products and actively contribute to corporate risk management related to safety.
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This role is pivotal in ensuring that our client remains a leader in patient safety and pharmacovigilance, fostering a culture where safety is integrated into every aspect of our drug development process.
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Demonstrated knowledge of principles of drug development, pharmacology, clinical trial methodology and design, medical monitoring of trials, assessment of drug risks and benefits, and safety assessment of drugs both on the market and in development and global safety regulations highly preferred.
$322,000 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Extensive experience (10+ years) in drug safety and pharmacovigilance within the biotech or pharmaceutical industry, including significant leadership experience. Champion excellence in drug safety and pharmacovigilance practices throughout the company.
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Collaborate with senior executives to integrate drug safety & pharmacovigilance considerations into overall business strategies, clinical development plans and broader decision-making processes.
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Act as a safety representative and facilitator between external reporting sources such as call centers, CROs and investigator sites, interface with internal departments clinical operations, medical information, regulatory affairs, product development, quality assurance, biostatistics, data management, and legal.
$42 an hourFull-timeExpandApply NowActive JobUpdated 14 days ago - UpvoteDownvoteShare Job
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MD, PhD or Pharm D with specialty training in functional area at least 10 plus years of experience in pharmaceutical industry within Drug Safety / Pharmacovigilance with both investigational and marketed products.
$322,300 a yearFull-timeExpandApply NowActive JobUpdated 6 days ago - UpvoteDownvoteShare Job
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Do you have 10+ years of experience in drug development and in drug safety/pharmacovigilance? If you are a strong problem-solver, agile with regulations and requirements for global safety surveillance & safety risk management in drug development and post-marketing settings, and enjoy cross-functional partnerships, this is the role for you.
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Final review or author for all regulatory safety documents, e.g., Periodic Benefit Risk Evaluation Reports (PBRERs), Periodic Adverse Drug Experience Reports (PADERs), Development Safety Update Reports (DSURs), template informed consents, Investigator Brochures.
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Key success factors for the position include rare disease, cardiometabolic disease or immuno-oncology drug development experience, creativity, integrity in thought and action, team-centric mindset, integrative thinking, ability to influence decision-making, exceptional communication skills, the ability to inspire, and being a “hands-on doer.
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Minimum 10 years’ experience in drug safety/pharmacovigilance within clinical development. Collaborate with Clinical Development, Regulatory Affairs, and other key departments to promote a robust drug safety culture.
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Health Care Professional degree required (e.g., RN/BSN/MSN, NP, PharmD) and 8+ years of pharmaceutical industry experience in drug safety & pharmacovigilance as a Safety Scientist for products in the clinical trial and post-marketing environments or MD with 4+years of clinical experience and 6+years of pharmaceutical industry experience in Safety Science, Clinical Development, or Clinical Research is preferred.
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drug development jobs Title: safety in Boston, MA
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