24 June, 2022
AstraZeneca is hiring for Manager – Patient Safety Scientist (Pharmacovigilance)
Experience: 6 – 9 years of relevant experience in Pharmacovigilance
Perform all Surveillance activities including periodic report production, leading monthly signal-detection activities and SIRC activities for established products.
Authors/provides strategic input or oversight for periodic regulatory documents (PBRERs, PSURs, DSURs) according to the agreed process and timelines.
Able to produce of high-quality and timely responses to safety queries
Identifies and uses appropriate sources of information and database searches to retrieve relevant data for evaluation of signals for all products in area of responsibility.
Support a performance-driven culture
Raises appropriate concerns/issues to senior staff in a timely manner.
Safety Strategy and Management Team (SSaMT) leader for slightly complex products
Should be able to perform end to end Pharmacovigilance activity independently on 2 or more established products and should mentor others within their role.
Ensure compliance with global and local procedural documents and local implementation of Patient Safety objectives, policies, processes and procedures
Compliance with relevant procedural documents Provide strategic & scientific input into regulatory authority submissions, queries, and discussions
Support response to queries/impositions by regulators, with high level of attention to implications in other countries
Ensure good communication and guidance to AZ products
Liaise effectively and maintain excellent relationship with external contacts
Minimum Requirements –Education and Experience
Qualified to degree level in biosciences or an equivalent healthcare or pharmaceutical industry background, with proven competency in patient safety/clinical development
Comprehensive understanding of applicable Patient Safety regulatory obligations in EU
6 to 9 years Patient Safety experience (with clear evidence of delivery