Pharmacovigilance (Drug Safety) Officer

Due to commitment to the growth of the licensed product portfolio an exciting opportunity has arisen to work within the Pharmacovigilance (PV/drug safety) section of the Regulatory Affairs team at Torbay Pharmaceuticals (TP).

The PV Officer role is a permanent position, 30 hours a week

At TP we offer flexible working and this role has the potential to be 90% working from home where we’d only need to come to the office at agreed times.

Main duties of the job

You will be responsible for undertaking pharmacovigilance activities to support existing UK and International licensed products. No two days are ever the same; you will be part of a small team of professionals who enable TP to deliver against its growing licensing business opportunities whilst ensuring compliance with all relevant pharmacovigilance legislation.

The main tasks of this role include:

  • Support the Pharmacovigilance Manager with management of the company PV System
  • Co-ordinate the ASPR work flow process from downloads to review & collation
  • Co-manage the literature searching activity & associated actions
  • Evaluate & process adverse event cases
  • Assist with the management of PV Agreements with distributors and licensing partners
  • Generate safety reports for TPs licensed products

Starting Salary: £27055.00 per annum, pro rata

For more details or To APPLY Click Here

We support remote and hybrid working where appropriate

For further information or to arrange an informal visit please contact:

Jacqui Winston, PV Manager

Person specification

Qualifications
Essential criteria

  • Degree in relevant subject area or equivalent experience 2 years+ experience of working within the pharmaceutical PV industry

Desirable criteria

  • PIPA membership

Experience
Essential criteria

  • Experience of LSA downloads & Article 57 submissions

Desirable criteria

  • Experience of generic manufacturing and branded pharma

Knowledge
Essential criteria

  • Excellent knowledge of UK & EU PV legislation
  • Knowledge of routes of licence application (legal basis)

Skills
Desirable criteria

  • Project Management
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