PV Manager

5 days ago


Helsinki, Uusimaa, Finland PharmaLex Full time

We have an exciting opportunity for a Sr PV Manager to join our supportive and growing team here in Pharmalex Finland

The main responsibilities will include:

  1. Set up and manage the local pharmacovigilance system.
  2. Ensure PV training of affiliate employees, service providers, and Third Parties.
  3. Provision of pharmaceutical expertise in the entire field of pharmacovigilance.
  4. Case Management.
  5. Knowledge and oversight of the entire ICSR process from intake to reporting, how this process impacts other services in SCS (aggregated reports, compliance, signalling, etc.), and provide guidance to applicable teams performing these tasks.
  6. Oversight of team PV activities including ICSR reporting, reconciliations, follow-up requirements, literature screening, signalling, inquiry, and complaint management.
  7. Communication with regulatory authorities and clients regarding all pharmacovigilance-focused aspects.
  8. Review and approve safety update reports PSURs (Periodic Safety Update Reports), PADERs (Periodic Adverse Drug Experience Reports), DSURs (Development Safety Update Reports), risk management plans, and signal detection reports required and in support of risk-benefit profiling.
  9. Writing/Review of procedural documents such as Working Instructions, SOPs, Working Procedures, Templates, etc. for PharmaLex PV projects.
  10. Organize and perform training of the above-mentioned procedural documents.
  11. Preparation of and participation in internal and external PV audits/inspections.
  12. CAPA review and approval.

Minimum Qualifications:

  1. Several years' experience and profound knowledge in the field of pharmacovigilance.
  2. Expertise, experience, and knowledge regarding relevant legislative and non-legislative guidelines on pharmacovigilance.
  3. Demonstrable ability in leading, mentoring, managing, and motivating staff.
  4. Ability to lead project teams, distribute work equally and according to team members' strengths as well as achieve commitment according to project milestones.
  5. Ability to manage internal and external (client) relationships at the level of client's department heads; ability to discuss and align mid-term goals of collaboration.
  6. Very good communication skills (written and verbal); proven capability to communicate critical issues and propose appropriate (cross-divisional) solutions to decision-makers. Good presentation skills.
  7. English business fluent & Finnish.
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