Pharmacovigilance Co-ordinator

Walker Cole International is searching for a Pharmacovigilance Co-ordinator to join an established pharmaceutical business based in the South East of England.

Your responsibilities will be to:

• Develop and authorize artwork components and patient information materials (SPC, PIL, cartons, labelling), including associated mock-ups.
• Coordinate with contractors to submit safety and PSUSA variations, as well as update and approve risk minimization materials (RMMs).
• Upload RMMs to databases such as EMC.
• Complete detailed monthly PV Summaries.
• Review and supply sales data for PSUR reporting.
• Ensure all relevant contracts are in place for PV activities conducted by external parties in the UK & EU.
• Supporting the company and its stakeholders in their compliance with relevant regulations.

The successful candidate will have:

• A Life Science degree or equivalent..
• A few years of experience in pharmacovigilance and regulatory affairs.
• Proficiency in the use of MS Office suite (Excel, PowerPoint).
• Ability to take initiative and work with different departments as a team player within the organisation.
• Strong analytical and problem-solving skills.
• Ability to work in a dynamic and fast paced environment.

Pharmacovigilance | PV | GVP | Pharmaceutical | Good Pharmacovigilance Practice | SDEAs | Safety Data Exchange Agreements | Adverse Events | Drug Safety | MHRA | EMA | European Medicines Agency | SPC | PIL | PSUSA | EMC | Safety | Regulatory Affairs | RA | PSUR |