Senior Pharmacovigilance Officer
|Job Title:||Senior Pharmacovigilance Officer|
|Contact Name:||Richard Williamson|
|Job Published:||July 24, 2017 18:31|
The Senior PV Officer will support the PV Team Leaders and PV Manager in ensuring that day to day operational activities are completed. The Senior PV Officer will be responsible for client management, reviews and checks of aggregate reports and any ad-hoc projects, as required.
The Senior PV Officer will be expected to be professional, diligent and liaise with Senior members in the team on any issues. The Senior PV Officer is also expected to lead by example and ensure quality standards are upheld within the company.
The activities listed may not always be undertaken by the Senior PV officer, however these activities are within the remit of the role.
- Knowledge and use of the pharmacovigilance database for processing of Adverse Events (AE) and Adverse Drug Reactions (ADRs).
- Triage and QC sign-off of AEs and ADR reports.
- Testing for electronic submission via EudraVigilance for relevant Health Authorities as required.
- Submission of AEs and ADRs in the appropriate format to the Regulatory bodies, in compliance with the statutory timelines.
- Compilation and presentation of submission metrics.
- Organisation of all cases into a comprehensive documentation system.
- Review of literature searches and assessment of data for safety signals and ICSRs.
- Inform administrators of new contracts.
- Report writing and generation of meeting minutes.
- Review of SmPCs against market leaders SmPC for clients.
- EudraVigilance reporting and reporting of expedited cases as appropriate.
- Updating and adding clients' products to the xEVMPD (Extended EudraVigilance Medicinal Product Dictionary).
- Preparation and review of Development Safety Update Reports and Periodic Safety Update Reports.
- Assist senior team members and management in implementing and improving processes.
- Prepare and maintain client PV Systems Master file (PSMF).
- Prepare risk management plans (RMP), addendum to Clinical overviews (ACO) and Clinical Expert Statements (CES).
Client related activities
- Communication with internal and external customers.
- Act as Client Manager and back-up for clients and colleagues respectively.
- Performing the role of deputy Qualified Person for Pharmacovigilance (dQPPV) for clients.
- Performing the role of deputy Responsible Person for EudraVigilance (RP for EV) for clients.
- Participation in the team ethos to ensure a high standard of Client care.
Senior PV Officer Responsibilities
- Highlighting any areas of concern/discrepancies in the ADR arena to the Pharmacovigilance Manager/Associate Director.
- Pharmacovigilance training and mentoring of other members of the Team.
- Build confidence and share knowledge.
- Provide support and leadership to junior team members to ensure daily tasks are completed.
- Maintain an up to date knowledge of pharmacovigilance regulations.
- Monitor changes to the pharmacovigilance guidelines and work with Senior Management to implement the necessary operational changes.
- Participation in audits.
- SOP writing and maintenance.
- Participation in PV projects as required.
- Maintain contract database with all relevant documentation.
- Any other duties deemed necessary.
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