Senior PV Scientist

Modis Life Science is now looking for a Senior PV Scientist for a consulting assignment at AstraZenea in Gothenburg. The assignment will start in june and initially run for 12 months. Send your application ASAP, no later than May 26th

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.

Introduction:
The Senior Pharmacovigilance (PV) Scientist role leads the review of safety data and related documents for potential safety issues in collaboration with the Global Safety Physician (GSP) and other PV Scientists. He/she authors and leads PV input to safety documents and regulatory reports. Senior PV Scientist leads meetings and presents safety data and analyses.

Main Responsibilities:
• Leads and/or conducts proactive pharmacovigilance and risk management planning for more complex 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.
• Leads PS activities of cross-functional project teams for developmental compounds and/or marketed products.
• Leads and provides safety expertise to Investigator Brochures, Protocols, Informed Consents and Clinical Study Reports.
• Leads the cross-functional Safety Strategy and Management Team (SSaMT) for large and/or complex projects.
• Presents complex issues to Safety Information Review Committee (SIRC) and takes the lead role in data evaluation and discussion of the results with the SIRC Chair, GSP and other key stakeholders.
• Leads and authors the Reference Safety Information (RSI) for multiple and/or complex development products and collaborates with GSP and Clinical representatives as needed
• Authors/provides strategic input or oversight for multiple and/or complex periodic regulatory documents (PBRERs, PSURs, DSURs) according to the agreed process and timelines.
• Authors/provides strategic leadership to regulatory submissions for new products, formulations or indications (NDA/BLA, MAA), in partnership with the GSP and other functional experts.
• Trains and mentors junior members of the team, e.g. in approved PV processes, analytic methodologies, etc.

Requirements – Education and Experience
• A life sciences/pharmacy/nursing degree, and demonstrated Patient Safety and/or Clinical/ Drug Development experience
• Fluent in written and verbal English
• Advanced knowledge of PV regulations
• Intermediate understanding of epidemiology, preferred