The Principal Pharmacovigilance (PV) Scientist role provides expertise to multiple and/or single but complex products in different stages of development as needed. In this role you will provide oversight of safety documents and deliverables for these projects in collaboration with the Global Safety Physician (GSP) and other PV Scientists. You will lead PV strategy for safety documents and regulatory reports.
You will be responsible for leading the strategy for proactive pharmacovigilance and risk management planning of complex or multiple products, including preparation of the safety aspects of Global Risk Management Plans and Risk Evaluation and Mitigation Strategies (REMS) in partnership with the GSP and others as appropriate. You will provide subject matter expertise in the therapeutic area and across multiple products. You may lead cross-functional process improvement or other initiatives on behalf of the Patient Safety organization. You will be performing duties as a Safety Strategy and Management Team (SSaMT) Leader for complex and/or multiple products. As a Safety expert you will lead presentation of complex issues to Safety Information Review Committee (SIRC). You will lead safety strategy for multiple or complex periodic regulatory documents (PBRERs, PSURs, DSURs) according to the agreed process and timelines. You will lead safety strategy for regulatory submissions of new products, formulations or indications (NDA/BLA, MAA), in partnership with the GSP and other functional experts. You will be leading negotiations and provides expertise to the PS component of contracts/agreements with third parties to ensure quality and integrity of agreements. You will take accountability and lead resolution of complex safety issues and mediate cross-functional agreement. You may participate in due diligence activities. You will be responsible to provide training and mentorship to new GSPs and PV Scientists in approved processes and systems.
Essential Requirements