- Experience Level
- Experienced (non-manager)
Location: Gaithersburg, US
Competitive Salary & Benefits
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 an inspiring culture where we celebrate innovative thinking. Faced with complex disease challenges, we focus on exceptional performance to drive the world's best and most transformative drug development programmes.
We are looking for a Pharmacovigilance Scientist to join our Patient Safety Oncology team. You and your colleagues will be instrumental in delivering the safety strategy for your assigned drug development programme. You will spend your time aggregating, reviewing, analysing and interpreting safety-related data to generate information to support safety decision making by prescribers, patients and payers, with the ultimate goal of protecting patients.
Applying your pharmacovigilance and scientific knowledge, you will also have the chance to provide input to safety-related documents, e.g. regulatory periodic safety reports and safety content of marketing authorisation applications.
- A Bachelor's degree in life sciences/pharmacy/nursing degree or related field
- MSc/PhD in a scientific field preferred
- Demonstrable Patient Safety and/or Clinical/ Drug Development experience across a range of activities
- Solid understanding of PV regulations
- Intermediate understanding of epidemiology preferred
- Excellent communication skills in written and verbal English
- Clinical drug development (Early and/or Late Phase)
- Post-Marketing Surveillance
- MAA/BLA submissions
- Periodic Reports
- Risk Management Plans (authoring/working 'from scratch')
- Governance board interactions