Director/Head, Pharmacovigilance (Remote)
Skills
About the role
This is a remote director-level leadership role heading the pharmacovigilance (drug safety) function at a commercial-stage cell therapy company. It suits an experienced drug safety leader with people-management experience who can operate hands-on in a small biotech. The role reports to the Chief Development Officer and is based remotely, with the company's Menlo Park, CA office as an option.
What you’ll do
- Lead risk management, safety data review and analysis for the company's products.
- Provide safety content for clinical and regulatory documents.
- Lead inspection preparedness and represent the company at regulatory inspections.
- Update SOPs and documentation to reflect regulatory changes.
- Lead safety-related regulatory filing activities including RMPs, REMS and signal detection.
- Manage and mentor a small pharmacovigilance team.
What they’re looking for
- Advanced degree in a biologic/medical/clinical/nursing field (PharmD, NP, MD, or PhD).
- 10+ years of experience in drug safety, safety science and risk management, including people leadership.
- Knowledge of US and EU pre- and post-marketing pharmacovigilance regulations.
- Experience preparing PSURs, PBRERs, PADER and Risk Management Plans.
- Experience with clinical development, risk/benefit analysis and safety assessment.
- Prior experience working on a BLA/NDA.
Nice to have
- Prior experience leading risk management activities for a BLA/NDA.
- Knowledge of cell therapy, bone marrow transplant or hematology oncology.
- Experience in MedDRA coding and search strategies.
What’s on offer
- Pre-IPO equity and annual bonus.
- Medical, dental and vision benefits.
- PTO, 401(k), life and disability coverage, parental leave.
- Subsidized daily lunches and snacks at on-site locations.
Questions about this role
Is this role remote?
Yes, it's remote, with the option of the Menlo Park, CA office.
How many years of experience do I need?
10+ years in drug safety, safety science or risk management, including people leadership.
What degree is required?
An advanced degree such as PharmD, Nurse Practitioner, MD, or PhD.
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