Drug safety expert

We are looking for a Drug safety Expert for our pharmacovigilance team to Kuopio with 0.5 FTE position.

Description of tasks

The tasks would include, among other

• participating in the maintenance and development of the company's pharmacovigilance systems

• conducting pharmacovigilance audits

• handling of adverse effect and safety incident reports

• maintenance and development of electronic databases

• literature monitoring from international sources

• pharmacovigilance training

• PV intelligence

• risk management and risk minimization measures

• Signal detection

• coordination of national and international client projects and acting as a contact person

What we expect from you:

Strong work experience in pharmacovigilance activities, including, among others:

• handling of adverse events

• maintenance and development of electronic databases

• global literature monitoring

• risk management and risk minimization measures

• development and maintenance of pharmacovigilance documentation and operating instructions

• signal management

• subcontractor coordination

• Knowledge of EU legislation and GVP related to pharmacovigilance

• Previous experience with quality systems and performing audits

• Previous experience in the pharmaceutical industry and working in a regulated environment

• Service- and solution-oriented mindset

• Ability to work independently as well as in a team together with Medfiles or our clients' experts

• Fluent oral and written skills in English

• Relevant higher education degree in the Life Sciences field (B.Sc., M.Sc.)

In your work, you will have the opportunity to grow your expertise and utilize your skills in a very versatile manner. Available is a broad, interesting, and diverse specialist role in an international, flexible, and inspiring team. We offer our employees opportunities for continuous skill development and varied career prospects. At our company, both your expertise and your well-being are taken care of.

More information about the company can be found at https://medfilesgroup.com