Head of Pharmacovigilance
San Francisco Bay Area
A cutting-edge Oncology company is seeking a Head of Pharmacovigilance to join their team! This company has 13 indications in various stages of development with the most advanced of which with an NDA filed. This organization is set for some incredible growth over the next few years and while they are currently privately held, they have plans to IPO in 2021! You will receive Pre-IPO equity in this role so it can be extremely lucrative as well all while helping an inspiring mission of eradicating cancer! If interested in learning more don't hesitate to apply.
The Head of Pharmacovigilance will be responsible for:
- Accountable for day to day operational performance and compliance of global PV processes, SOPS, training and education. Implements pharmacovigilance standards across all development programs that are followed globally.
- Leads data reconciliation between clinical and safety databases data on a routine basis as well as serious adverse event report exchange with different sponsor company.
- Reviews and authors safety sections to study protocols, investigator's brochures, statistical analysis plans and other clinical study-related documents, in addition to contributing to pharmacovigilance risk management.
- Reviews adverse event data, literature, and other safety-relevant data in order to conduct proactive signal detection activities and leads data analysis to evaluate safety observations.
- Performs triage, review, and assessment of serious adverse events including analysis of similar events and ensures acquisition of appropriate information and timely global submissions as applicable.
- Directs the planning, preparation, writing and review of aggregate reports, including but not limited to, development safety update reports, periodic safety reports, etc.
- Performs periodic reviews of safety information and presentation of this information at Safety Review Committee meetings and cross functional teams as applicable.
- Leads internal audits and regulatory inspections and undertakes activities to maintain a state of inspection readiness.
- Lead the development of safety data exchange agreements, and safety management plans with internal and external stakeholders for clinical studies and ensure compliance.
- Reviews MedDRA/WHO Drug Coding as developed by Safety CRO.
- Provide guidance to pharmacovigilance department in China as needed.
- Leads the oversight of Safety CRO and related Study CROs by ensuring safety functions and deliverables are of high quality in alignment with Master Service Agreement and applicable Statements of Work.
Ideal Candidates will have:
- MD., or foreign equivalent, or PhD.
- Experience with Oncology from a clinical or industry setting.
Ten plus years' experience in safety monitoring and pharmacovigilance required.