Principal Safety Surveillance & Risk Scientist
A well-known global pharmaceutical company with leading products across various therapeutic areas is looking to hire a Principal Safety Surveillance & Risk Scientist. This vacancy is an exciting opportunity to work at a top global pharmaceutical company that has a workforce of more than 6,700 employees across multiple sites in the UK.
- Leading the strategy for proactive pharmacovigilance and risk management planning of complex or multiple products, including preparation of the safety aspects of Global Risk Managing Plans and Risk Evaluation and Mitigation Strategies (REMS) in partnership with the GSP and others as appropriate.
- Providing subject matter expertise in the therapeutic area and across multiple products.
- Ability to lead cross-functional process improvement or other initiatives on behalf of the Patient Safety organisation.
- Perform duties as a Safety Strategy and Management Team (SSaMT) Leader for complex and/or multiple products.
- Leading presentation of complex issues to Safety Information Review Committee (SIRC).
- Leading the safety strategy for multiple or complex periodic regulatory documents (PBRERs, PSURs, DSURs) according to the agreed process and timelines.
- Leading the safety strategy for regulatory submissions of new products, formulations or indications (NDA/BLA, MAA), in partnership with the GSP and other functional experts.
- Leading negotiations and provides expertise to the PS component of contracts/agreements with third parties to ensure the quality and integrity of agreements.
- Take accountability and lead resolution of complex safety issues and mediates cross-functional agreement.
- Ability to participate in due diligence activities.
- Providing training and mentorship to new GSPs and PV Scientists in approved processes and systems.
Skills and Requirements:
- A life sciences/pharmacy/nursing degree, and advanced Patient Safety and/or Clinical/Drug Development experience.
- Advanced knowledge of PV regulations.
- MD/MSc/PhD in a scientific discipline preferred.
- Advanced understanding of epidemiology, preferred.
- Demonstrable experience working in/leading (safety &/or scientific) activities across at least 4 of the following areas:
- Clinical Development (Early and/or Late Phase).
- Post-Marketing Surveillance.
- MAA/BLA Submissions.
- Periodic Reports.
- Risk Management Plans (from scratch).
- Governance Board Interactions.
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency in computer skills, such as MS Office.
- Fluent in written and verbal English.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Kevin Hansberry at 0207 440 0636 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
# Drug Safety