QA Manager (GVP)

We are looking for a QA Manager (GVP) to join our QA team.  You are a quality assurance professional with a background in pharmacovigilance.  The QA tasks include participating in the maintenance and development of the company's quality system and documentation, management of general QA issues, internal/external/vendor audits, system validation, training of Medfiles personnel, and supporting the pharmacovigilance team with legislation and GVP matters. This is a full-time position, but 0.8 FTE can also be considered.

Medfiles is a leading CRO in the Nordic and Baltic countries. You would be located at one of the Baltic offices in Tartu (Estonia), Riga (Latvia) or Kaunas (Lithuania) or at one of the Finnish offices in Vantaa, Kuopio or Tampere or work remotely in one of the mentioned countries.

• Strong work experience in pharmacovigilance, including but not limited to:

  - handling of adverse events

  - maintenance and development of electronic databases

  - local and global literature screening

  - risk management and risk minimisation measures

  - development and maintenance of pharmacovigilance documentation and SOPs

  - signal management

  - vendor coordination

• Prior experience from the pharmaceutical industry and regulated environment.
• Service- and solution-oriented mindset.
• Ability to work both independently and in a team with other Medfiles’ or our clients’ experts
• Fluency in spoken and written English, plus proficiency in one of the following languages: Estonian, Latvian, Lithuanian, or Finnish.
• An applicable life science university degree (B.Sc., M.Sc.).

In your work, you will be able to utilize and develop your expertise in our quality team. You will work closely with Medfiles’ PV team and QPPVs. We offer a wide, interesting, and versatile expert position in our international, flexible and inspiring work community. In addition to flexible working practices we support the well-being of our employees with a variety of benefits.

We offer:

- Workload: Full-time (0,8-1,0 FTE).

- Contract: Permanent.

- An international working environment.

- Chance to work in a friendly and supportive team.

- Additional employee benefits (incl. health insurance, additional vacation).

- Flexible working conditions.

For more information on our company and the position, please contact Head of QA Maria Likander by phone at +358 50 3102856.

Additional information on the company can be found at https://medfilesgroup.com .

Please send your motivation letter (including salary expectation) and CV in English.

Starting time: As soon as possible. Position will be filled as soon as a suitable candidate has been found.