Principal Patient Safety Scientist, Vaccines

**Job Description - Principal Patient Safety Scientist, Vaccines & Immune Therapies**

**Location - Onsite in Gaithersburg MD or Waltham MA or Mississauga Canada**

At AstraZeneca we work together across global boundaries to make an impact and find answers to challenges. We do this with the upmost integrity even in the most difficult situations because we are committed to doing the right thing. We continuously forge partnerships that help pursue world-class medicines in new ways, combining our people’s exceptional skills with those of people from all over the globe.

As a Principal Patient Safety Scientist in Vaccines & Immune Therapies (V&I), you will play a pivotal role in channeling our scientific capabilities to make a positive impact on patient’s lives. In this exciting and challenging role, you will be involved in aggregating, reviewing, analyzing 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. You will work collaboratively with the Global Safety Physician (GSP) and other PV Scientists and physicians playing a role supporting the safety strategy and requirements for your assigned drug project(s). Your ability to work collaboratively will facilitate cross-functional interactions with colleagues from across AstraZeneca, including counterparts within Clinical Project Teams, Global Regulatory Affairs, and Global Commercial teams.

You will join us in driving development of our innovative and emerging pipeline, transforming exciting science into valued new medicines and ensuring patients around the world can access them. You will be representing the voice of patients in the development, maintenance and use of our medicines.

**Main Duties and Responsibilities**

As Principal Patient Safety Scientist V&I, you will provide expertise to multiple and/or single but complex products in different stages of development as needed. In your role, your contributions and impact will be great Your day to day will include:

- Provide oversight of safety documents & deliverables for these projects in collaboration with scientists and the Global Safety Physician
- Lead the PV strategy for safety documents and regulatory reports
- Ensure proactive pharmacovigilance and risk management planning of complex or multiple products to include:

- preparation of the safety aspects of Global Risk Management Plans and Risk Evaluation and Mitigation Strategies (REMS) in partnership with the GSP
- lead cross-functional process improvement or other initiatives on behalf of the Patient Safety organization
- perform required activities as a Safety Strategy and Management Team (SSaMT) Leader for complex and/or multiple products
- be recognized as a Safety expert and lead presentation of complex issues to Safety Information Review Committee (SIRC)
- 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), in partnership with the GSP and other functional experts
- lead negotiations and provide expertise to the PS component of contracts/agreements with third parties to ensure quality and integrity of agreements
- are accountable for and will lead resolution of complex safety issues and mediate cross-functional agreements
- may participate in due diligence activities
- responsible for ensuring training is provided and mentorship is assigned to new GSPs and PV Scientists within the established systems & processes

**What We Are Looking For**

**Essential Requirements**
- BS degree in life sciences related field
- 5+ years of directly related PV experience combined with life sciences/pharmacy/nursing training and advanced Patient Safety and/or Clinical Drug Development experience.
- Fluent in written and verbal English
- Advanced knowledge of PV regulations

**Preferred Qualifications**
- MD/MSc/PhD in scientific discipline
- Advanced understanding of epidemiology

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