Pharmacovigilance Regulatory Affairs Manager, UK
We have an opportunity for an experienced PV professional to join our team in the UK. We are looking for a dynamic and flexible individual who has a consultative approach to their work. We work with a broad selection of pharmaceutical, biotechnology and device clients across the globe and each project can vary significantly.
This role is to provide technical writing support for one of G&L’s major clients, working closely with their Regulatory, Clinical and Safety teams.
Duties will include:
- Provide technical writing support to the Pharmacovigilance Operations and Clinical Safety Risk Management functional owners aiding in the development, governance (change control), and maintenance of SOPs and related procedural documents.
- Responsible for a large number of procedural documents within the PV/Safety realm including the working drafts, updated drafts, and final versions.
- Technical writing support and expertise with the procedural documents focused on the following PV/Safety sub-functions:
- Medical Safety Management – Device and Drug-Device Combination Products
- Medical Safety Review
- PV Business Operations, Systems and Quality Management
- Safety Management – Aggregate Safety Report Quality
- Safety Management – EU QPPV
- Safety Management – Post Approval Safety Monitoring
- Safety Management – PSUR and Associated Reports
- Safety Management – Risk Management
- Signaling/Surveillance and Risk Management
- Project activities to include developing and updating procedural documentation for both PV/Safety processes and systems end user materials working with various business SMEs and functional owners:
- Develop, write, edit, and format materials such as Standard Operating Procedures, Business Practices, forms, checklists, technical manuals, installation guides, user manuals, and related technical and business process documentation.
- Facilitate reviews with project managers and various business SMEs, updating draft documents and working with SMEs and document owners to finalize. Works with leads to schedule reviews, capture comments, and update documents
- Administer the processing of documents via the established Document Processing Review process
Our team of consultants are expected to be ambassadors for G&L. Working directly with clients and Health Authorities we really value communication skills and the art of negotiation and diplomacy.
All our staff are encouraged to have the confidence to speak their mind and suggest new ideas. All our consultants are expected to act as mentors to junior staff, contributing to the development of graduate and junior training programs.
Above all, our company is all about our people – so you should have a passion for meritocracy, recognition, and development.
We hope that you will feel excited about making suggestions or challenging existing methodologies. G&L’s reputation has been built on our customer service and client-focus so any ideas that will help us stay ahead of the curve are encouraged.
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