| Requirement |
Lead scientific, technical or Patient Safety input for a product, group of products, systems or processes. He/she has the ability to provide authoring and PV input to safety documents and regulatory reports. PV Scientist also has the ability to lead meetings and present safety data and analyses
Accountabilities/Responsibilities
- 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 high-quality and timely responses to safety queries
- Identifies and uses appropriate sources of information and database searches to retrieve relevant data for the evaluation of signals for all products in the 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 a 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
|