Senior PV Officer (LPPV/QPPV)
- Experience Level
- Experienced (non-manager)
- Full-time permanent position
- Office based in Surrey
- Competitive package
- Global pharma company
- Responsible for the establishment and maintenance of the UKI pharmacovigilance system, coordinating the day-to-day management of the pharmacovigilance system in the UK and Ireland and ensuring local compliance with applicable Regulations and Corporate policies (local and global).
- Appointed to local HA as national contact person for pharmacovigilance or QPPV as applicable.
- Responsible for the establishment and maintenance of the UKI pharmacovigilance system.
- Establish and maintain a system of collection, assessment and submission of information on adverse reactions, lack of efficacy, AEFI, other data relating to safety and efficacy in accordance with the legal requirements and GVP.
- Responsible for the PSMF that describes the pharmacovigilance system for UK authorised products (‘the UK PSMF’).
- Intake / forwarding of Adverse Events with or without Product Technical Complaints and special situations to Global Pharmacovigilance & Risk Management (GPRM) or partner (as applicable); documentation and tracking of AEs; reconciliation activities and documentation.
- Perform follow-up activities as applicable and document (these include targeted questionnaires).
Full job description available on application
- Candidates should have a life science degree as a minimum;
- Knowledge of domestic and international Pharmacovigilance regulations; Experience in dealing with local regulatory agencies;
- At least 3 years experience in pharmacovigilance and experience in local responsible person;
- Skills for the management of pharmacovigilance systems
- Only candidates with existing right to work in the UK/EU will be considered
Please complete the details below to apply. For further information or a discreet discussion regarding your recruitment requirements, please call Alex on 01227 844466 or email email@example.com
To view our other vacancies, please visit our website on www.apexrecruitment.com
Apex Recruitment are a specialist agency providing opportunities within the pharmaceutical, biopharma, biotech and medical device industries recruiting in the areas of medical affairs, drug safety, clinical and quality.
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