Specialist, Pharmacovigilance

2 months ago

Maidenhead, United Kingdom ABBVIE Full time

Supports the development of local processes that clearly define the pharmacovigilance responsibilities and requirements within the affiliate in line with all applicable AbbVie Standard Operations Procedures and processes, the Code of Conduct and the local legislation.
- Ensuring PV training compliance with global and local training requirements for both affiliate AbbVie employees and UK third party vendors, maintenance of relevant training documentation as applicable and reporting of training metrics to relevant global and local functions as required.

**Core Responsibilities**:
Responsible for annual review of AbbVie owned websites.Oversight and maintenance of UK PV dashboards to include escalation and investigation of non-compliance to Global teams and UK ASR/QPPV.Where delegated, is a point of contact for communication with regulatory authorities on drug safety issues and ensures that all regulatory authority communications are forwarded to the required UK and PPS personnel.Responsible for reviewing SOW/relevant annexures for Third Party case processor with regards to ICSR processing and other outsourced PV activities.Supports the development and maintenance of local procedures that are in line with global requirements and UK legislation.Creates periodic compliance reports, reporting relevant compliance metrics to PPS/ IPEx/leadership and follows up the results to ensure robust documentation.Regularly researches national regulations and laws, forwarding notifications of new regulations to UK ASR, Global Regulatory Intelligence and International Pharmacovigilance Excellence (IPEx)Monitors ongoing reconciliation processes with interacting departments and partner companies/service providers with follow-up of discrepancies where applicable. Partnering with Therapy Area Specialist/Manager to support vendor reconciliation processes where requested.Follow up of ICSRs where Third Party case processor is unable to directly follow-up.
- Responsible for the creation and maintenance of UK PSMF annexes related to UK PV system compliance, training and issue management processes.Responsible for annual literature review process and routine monitoring of list of journals reviewed for adverse events.Communication of safety related notifications from the QPPV office to relevant stakeholders in the affiliate, including the Head of PV UK and Affiliate Medical Director (AMD)
- Degree in life sciences (medicine, veterinary medicine, pharmacy, (human) biology etc.)
- Pharmacovigilance experience required preferably across the PV system
- High degree of familiarity with UK and EU legislation/regulatory requirements
- Ability to develop and maintain strong collaborative relationships with internal and external stakeholders
- Experience in conducting training sessions desirable
- Team orientated. Ability to deal with conflicting interests within a multi-functional team and the skills to bring these interests together towards a common goal; ability to manage and work closely within a team in a matrix organization
- Works independently: limited guidance/oversight
- Ability to prioritize, strong planning and excellent organizational skills and the ability to get things done

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