Principal PV Scientist

Hobson Prior are looking for a Principal PV Scientist to join a leading biopharmaceutical organisation who provide pioneering medicines to patients all over the world. As the Principal PV Scientist, you will provide expertise to multiple and/or single but complex products in different stages of development as needed.

Job Responsibilities:

• Lead 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.
• Provide subject matter expertise in the therapeutic area and across multiple products.
• You will have the ability to lead cross-functional process improvement or other initiatives on behalf of the Patient Safety organization.
• You will take accountability and lead resolution of complex safety issues and mediates cross-functional agreement.
• Complete duties as a Safety Strategy and Management Team (SSaMT) Leader for complex and/or multiple products.
• 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 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 lead negotiations and provides expertise to the PS component of contracts/agreements with third parties to ensure quality and integrity of agreements.

Key Skills:

• Fluent in written and verbal English.

Requirements:

• A life sciences/pharmacy/nursing degree.
• Advanced Patient Safety and/or Clinical/Drug Development experience.
• Advanced knowledge of PV regulations.
• MD/MSc/PhD in scientific discipline would be preferred.
• Advanced understanding of epidemiology would be preferred.

Apply now:

If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.