​Director of Safety/Pharmacovigilance

Location Cambridge, Middlesex, Massachusetts
Discipline: Data Science
Job type: Permanent
Salary: £Competitive salary and benefits
Contact name: Josh Jess

Contact email: josh.jess@rbwconsulting.com
Contact phone: +1 (617) 982 1238
Job ref: JJ-DI-DAPH-MA
Published: about 1 month ago
Expiry date: 28 July 2021

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.

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

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

This position can be fully remote.

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

Competitive salary and benefits