Pharmacovigilance Specialist UK
Permanent / UK
Pharmacovigilance/ Drug safety Specialist - Greater London
Our client is currently recruiting for a Pharmacovigilance Specialist to lead their pharmacovigilance team in the UK. The company is known for its development of personnel and the quality of the work produced.
- Manages all pharmacovigilance (PVG) aspects of allocated studies.
- Ensures that all assigned projects are set-up in line with the client or sponsor specifications, the PVG standard approach, Standard Operating Procedures (SOPs)/Working Practice Documents (WPD) and relevant guidelines.
- Ensures that there is adequate ongoing review of output throughout processing to assess accuracy and quality.
- Ensures that for all assigned projects the PVG tasks are completed accurately, on time and within budget.
- Serves as a contact for PVG issues (backed up by study lead as appropriate). This includes effectively liaising with Sponsors, Project Managers and internal staff.
- Responsible for the collection, submission and filing of all safety data from client companies, including Serious Adverse Event (SAE) reports from clinical trials, spontaneous reports for marketed products and reports from the literature.
- Assists the Pharmacovigilance Manager and other project staff in writing bids, contracts and other project related documents. Assist in the preparation of Standard Operating Procedures (SOPs) and Working Practice Documents (WPDs).
- Responsible for ensuring the implementation and development of all pharmacovigilance systems, including performing validation procedures under supervision as necessary.
- Responsible for activities relating to EudraVigilance registration on behalf of client companies.
- Producing such safety reports as might be required for Periodic Safety Reporting to Regulatory Authorities.
- Bachelor's or higher graduate degree in a science related field, or equivalent experience
- This experience should include a proven understanding of the PVG process and experience in leading a project to successful completion.
- Excellent organisational and interpersonal skills Ability to co-ordinate, manage and motivate a team Process orientated with good attention to detail
- Effective oral and written communication skills
- Good computer skills and the ability to learn appropriate software Good understanding of safety database software, MS Word, MS Excel Good English language and grammar skills
- Good medical/therapeutic area knowledge and medical terminology preferred
Key Words: Pharmacovigilance, Drug Safety, Pharmaceuticals, PV, EU QPPV, PVG, EudraVigilance, , Market Leader, Safety Database, UK, United Kingdom, London
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