Clonmel, Co. Tipperary – Part-Time/Permanent
Niche Generics Limited is a generic pharmaceutical company whose products are registered and marketed in the UK, EU, South Africa, Australia and New Zealand. We currently have a vacancy for an experienced, part-time Pharmacovigilance Officer based in our office in Clonmel, Co. Tipperary.
The Pharmacovigilance Officer will liaise with external contract pharmacovigilance service providers and licensing partners to co-ordinate activities in compliance with current EU and UK requirements.
The ideal candidate will be a life science or pharmacy graduate, with a minimum of three years’ experience in pharmacovigilance. Key responsibilities will include:
- Overseeing maintenance of the Pharmacovigilance System Master File (PSMF)
- Writing and updating in-house pharmacovigilance SOPs
- Provision of information to contract pharmacovigilance service providers related to MAs
- Reporting to QPPV to ensure QP oversight in relation to safety variations
- Receipt and co-ordination of medical queries and ADRs
- Review and co-ordination of Safety Data Exchange Agreements
- Review of PRAC/regulatory authority updates related to safety information
- Assisting with pharmacovigilance audits and inspections
- Review pharmacovigilance compliance reports and change notifications received from service providers
- Review documentation prepared by pharmacovigilance service providers for regulatory submissions (eg. RMPs, ACOs, CESs)
- Participation in Drug Safety Review Meetings with pharmacovigilance service providers
- Co-ordinating annual pharmacovigilance staff training
A sound knowledge of the key aspects of the European and UK pharmacovigilance systems is required. Strong communication and interpersonal skills are essential together with a methodical approach to working and a high degree of computer literacy.
A competitive salary commensurate with experience is offered together with a generous benefits package.
To apply for this position please send your CV to firstname.lastname@example.org or fill the application form below.