Principal Pharmacovigilance Scientist
Cambridge, England, United Kingdom
Global Medicine Development drives late-stage development of our innovative pipeline, transforming exciting science into valued new medicines and ensuring patients around the world can access them. We are responsible for enabling the business to make critical pipeline and investment decisions, to ensure they select the right molecules to progress and to seize the right lifecycle management opportunities – generating the data required to drive regulatory submissions for new medicines and expanded indications and generating the evidence that shows their true value.
As the Principal Pharmacovigilance (PV) Scientist you will provide expertise to multiple and/or single but complex products in different stages of development as needed. 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.
The role would suit someone with scientific curiosity, and an enthusiasm for understanding the science and making a difference to patients. The remit of the role is flexible, with the unique opportunity to move around from early phase through to late phase and to post marketing. This allows for a wide breadth of experiences, opportunities to learn, grow and develop. Our team is enthusiastic, resilient and has a strong desire to follow the science. The pace is fast, with a new challenge each day.
You will 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.
You will 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 perform 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
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.
You will take accountability and lead resolution of complex safety issues and mediates cross-functional agreement.
You will have the ability to participate in due diligence activities.
As a safety expert, you will also provide training and mentorship to new GSPs and PV Scientists in approved processes and systems.
- A life sciences/pharmacy/nursing degree, and advanced Patient Safety and/or Clinical/Drug Development experience
- Fluent in written and verbal English
- Advanced knowledge of PV regulations
- MD/MSc/PhD in 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
If you are interested in this role please apply by submitting your CV. Thank you.
AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, gender or gender orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law.
AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.