AstraZeneca contributes meaningfully to the UK beyond the provision of our medicines and the benefits they provide to the health of the nation. We commissioned a report in 2009 to measure our significant investment to the UK economy, which includes investment in jobs and wealth creation. Oxera, an independent economic consultancy provided the analysis for this report.
Post : Manager, Patient Safety Scientist
Job Description
• Perform all surveillance activities including periodic report production, leading monthly signal-detection activities, and SIRC activities for established products.
• Author/provide strategic input or oversight for periodic regulatory documents (PBRERs, PSURs, DSURs) according to the agreed process and timelines.
• Produce high-quality and timely responses to safety queries.
• Identify and use appropriate sources of information and database searches to retrieve relevant data for evaluation of signals for all products in your area of responsibility.
• Foster a culture devoted to growth and achievement.
• Raise appropriate concerns/issues to senior staff in a timely manner.
• Lead the Safety Strategy and Management Team (SSaMT) for established products.
• Perform end-to-end pharmacovigilance activities independently on established products.
• Ensure compliance with global and local procedural documents and local implementation of Patient Safety objectives, policies, processes, and procedures.
• Provide strategic and scientific input into regulatory authority submissions, queries, and discussions.
• Support responses to queries/impositions by regulators, with a high level of attention to implications in other countries.
• Ensure good communication and guidance to AZ products.
Candidate Profile
• Qualified to degree level in biosciences or an equivalent healthcare or pharmaceutical industry background, with proven competency in patient safety (pharmacovigilance)/clinical development.
• Comprehensive understanding of applicable Patient Safety regulatory obligations in the EU.
• Awareness of Patient Safety policies, processes, and procedures.
• Awareness of medico-legal aspects of patient safety.
• 4 to 7 years of Patient Safety experience (with clear evidence of delivery).
• Total of 7 to 10 years of experience.
Desirable Skills / Experience
• Ability to work effectively as a member of a cross-functional or distributed team.
• Ability to work with autonomy.
• Ability to acquire and assimilate knowledge in different fields, disease, and therapeutic areas.
• Good communication skills with the ability to work across cultures.
• High ethical standards, including a commitment to AstraZeneca values and behaviors.
• Ability to appreciate diversity and work as equals with global and cross-functional teams.
Communication :
• Well-developed interpersonal skills.
• Cultural sensitivity.
• Ability to network with other functions globally.
Additional Information
Experience : 4 to 7 years
Qualification : degree level in biosciences
Location : Bangalore
Industry Type : Pharma/ Healthcare/ Clinical research
Job ID : R-222120
End Date : 4th April 2025
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