Principal Pharmacovigilance Scientist
4 days left
- Experience Level
At AstraZeneca, we make a difference every day by delivering life-changing medicines to millions of people globally. Our purpose is ambitious and so is our approach. Creating a more agile and inclusive environment means building a culture where we celebrate innovative thinking.
Our Patient Safety team sits within the Chief Medical Office; an integrated, enterprise-wide organisation dedicated to defining the benefit/risk assessment of our medicines across the life-cycle, acquiring and maintaining health authority approvals around the world. AstraZeneca's oncology pipeline, which includes novel combinations and modalities, provides a unique intellectual opportunity for colleagues with pharmacovigilance and Oncology experience. We aim to grow our teams' experience develops as our portfolio does.
The Principal Pharmacovigilance Scientist ais the highest level individual contributor scientist in our team structure before a team member elects to stay in technical project facing tract or moving into leadership tract leading and managing individuals within our organization. We are looking for someone who can demonstrate leadership within our environment and lead on complex PV projects through safety science expertise . You will lead PV strategy for complex products in different stages of development through input and delivery of safety documents and regulatory reports.
AstraZeneca offers the unique opportunity to move from early phase through to late phase and to post-marketing, giving you a wide breadth of experiences and continuous opportunities to learn, grow and develop. Our team is enthusiastic, resilient and has a strong desire to push the boundaries of science. The pace is fast, with a new challenge each day.
- Provide subject matter expertise in the therapeutic area and across multiple products
- Lead the strategy for proactive PV 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 Global Safery Physician and others as required.
- Lead cross-functional process improvement or other initiatives on behalf of the Patient Safety organisation.
- Perform duties as Safety Strategy and Management Team Leader for complex and/or multiple products.
- Lead presentation of intricate issues to Safety Information Review Committee.
- Lead safety strategy for multiple or complex periodic regulatory documents (PBRERs, PSURs, DSURs) according to the agreed process and timelines.
- Lead safety strategy for regulatory submissions of new products, formulations or indications (NDA/BLA, MAA) with the GSP and other functional specialists.
- Handle negotiations and provide expertise to the PS component of contracts/agreements with third parties to ensure quality and integrity of agreements.
- Take accountability and lead resolution of safety issues and mediate cross-functional agreement.
- Participate in due diligence activities.
- Provide training and mentorship to new GSPs and PV Scientists in approved processes and systems.
- A degree in life sciences (or similar field) and advanced Patient Safety and/or Clinical/Drug Development experience
- Excellent written and verbal English
- Advanced knowledge of PV regulations
- PharmD/MSc/PhD in scientific field, preferred
- Advanced understanding of epidemiology, preferred
Proven 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