​Director of Safety/Pharmacovigilance

Location: Cambridge, MA

A fast-growing biotech in Cambridge, MA utilizing gene therapy for rare systemic diseases is seeking a Director of Pharmacovigilance to maintain safety governance oversight.

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Job Duties:

• Report directly to the VP of Clinical Development

• Providing day to day management of all activities pertaining to product safety and pharmacovigilance clinical development and post-marketing surveillance

• Responsible for ongoing safety data review and signal detection, management of serious adverse event reporting, aggregate safety reporting, management of risk-benefit profiles, risk management and mitigation plans for all clinical stage programs.

• Collaborate with appropriate clinical operations, clinical development, medical, quality, and regulatory counterparts and others across the business, to provide input and oversight for all safety and PV issues including authoring as appropriate and review of documents such as DSUR, IB, clinical study protocols, informed consent forms, DSMB charters, development plans, and INDs/CTAs

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Requirements:

• MD, DO or equivalent medical degree.

• At least 8 years of pharmaceutical industry experience, including at least 5 years in pharmacovigilance management roles.

• Exemplary background in Clinical Safety/Risk Management

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This position can be fully remote.

Please direct any questions and resumes to josh.jess@rbwconsulting.com

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Competitive salary and benefits