• Be responsible for the Clinical Safety strategy for assigned projects and products throughout all stages of development, including implementation and communication of the strategy at the project team/governance level.
• Reviews and endorses the Patient Risk Management Plan (PRMP)/Core Patient Risk Log (CPRL).
• Provides expertise to the medical content of the safety specification, pharmacovigilance plan and risk minimisation activities in the PRMP, CPRL and globally reviewed LRMPs.
• Represents PS on cross-functional Clinical Teams and/or Project Teams for developmental and/or marketed products.
• Provides medical input to ensuring that risk-minimisation strategies are implemented appropriately in relevant documents such as product reference safety information.
• Provides strategic clinical safety input into Clinical Development planning activities.
• Provides strategic and medical input to project specific safety requirements (PSSR). Reviews and provides technical input and approval for investigator brochures, protocols, informed consents, final study reports and external data monitoring committees as appropriate.
• Provides input on cross-functional ad-hoc teams set up to address urgent and important safety issues.
• May present safety information at clinical investigator and commercial meetings.
• Involved in all safety surveillance activities, may include medical review of individual safety cases (providing medical expertise and judgement), signal detection, evaluation and SERM activities for all products in area or responsibility.
• Provides medical input to regulatory supporting documentation for labelling updates.
• Provides medical input into Identification and utilization of appropriate sources of information and database searches to retrieve relevant data for evaluation of signals.
• Collaborates in routine signal management activities.
• Provides medical input to deliver accurate and fit for purpose safety evaluation documents with clear conclusions in response to internal or regulatory authority requests for safety data.
• Provides strategic input into responses to regulatory requests for local label deviations from the company core safety documentation.
Academic / Professional Qualification
• Medical degree
Technical / Skills Training
• Good knowledge of international guidelines ICH/GCP.
• Excellent knowledge of relevant local legislation.
• Drug development experience and good understanding of Clinical Study Process
• Good medical knowledge in AZ Therapeutic Areas.
• Excellence in pharmacovigilance and Patient Benefit risk assessment
• Good organizational skills with the ability to multi-task and prioritize assignments (planning and organizing)
• Fluent in written and spoken English
At least 5 years of Drug Development/Patient Safety experience in MNC
AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law. AstraZeneca only employs individuals with the right to work in the country/ies where the role is advertised.
AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.