Pharmacovigilance Specialist

We are recruiting for a Pharmacovigilance Specialist to join a company in the pharmaceutical industry, working remotely on a contract basis for 3 to 6 months.

The Location:
The role is based at our client’s site in Prague, allowing for remote in Europe.

The main purpose of the role will be to:

• Project manage activities such as Local literature monitoring management, Local ICSR management, Regulatory Intelligence, Risk Management Measures, product documentation (SmPC, IB), as well as Management of project related PV contracts (PVAs, SDEAs).
• Ensure the delivery of projects/tasks in accordance with client needs as per the contractual agreements and procedures in place.
• Provide training to project team members and other PV department employees on technical areas.
• Further responsibilities will include:
  • Improving teamwork collaboration by sharing best practices.
  • Effectively managing and building working relationships with all stakeholders.
  • Participating in audits and inspections.

Your Background:
To succeed in this role, you will:

• Come from a Life Science background combined with a previous Drug Safety experience.
• Have a detailed knowledge of PV processes, directives, regulations and guidelines (ICH, GVP, GCP, CIOMS, etc.).
• Have experience working with a safety database desirable.

For more information, please contact external recruiter, Borka Consulting AS:
André Borka at +47 908 31 871 or andre@borka.no.
All inquiries are treated confidentially.