Director, Principal Patient Safety Scientist Oncology

Location: Barcelona, Spain (on-site) 3 days working from the office and 2 days working from home.

Do you have expertise in, and passion for Pharmacovigilance? Would you like to apply your expertise to lead on complex PV projects in a company that follows the science and turns ideas into life changing medicines? Then AstraZeneca might be the one for you!

AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines for some of the worlds most serious diseases. But we're more than one of the world's leading pharmaceutical companies.

We are a science-based, leading and decisive Oncology enterprise united in our vision to eliminate cancer as a cause of death. The pioneers, we make bold moves that transform the way cancer is treated and truly improve patient outcomes. With one of the broadest and deepest Oncology pipelines in the industry, there are many opportunities to work with new and novel drugs and help discover whats next.

What you'll do

TheDirector, Principal Patient Safety Scientist within Oncology Patient Safety is 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.

Your duties and responsibilities are likely to include:

• 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 Safety 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

Essential for the role

• 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

• Clinical Development (Early and/or Late Phase)

• Post-Marketing surveillance

• MAA/BLA Submissions

• Periodic Reports

• Risk Management Plans (from scratch)

• Governance Board Interactions

Desirable for the role

• PharmD/MSc/PhD in scientific field

• Advanced understanding of epidemiology