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PV Officer - 1 year contract - Warsaw

PV Officer - 1 year contract - Warsaw

TheramexWarszawa, Mazowieckie, Poland
14 days ago
Job description

Job Purpose

Provide pharmacovigilance expertise to safety surveillance & risk management compliance; authoring aggregate safety reports.

Key Duties and Responsibilities

  • Performing signal detection and risk management activities under the guidance of the PV Physician; prioritising the risks and mitigation actions that provide value for patients;
  • Producing accurate and fit-for-purpose signal evaluation documents with clear conclusions in response to internal or regulatory authority requests for safety data;
  • Authoring and / or reviewing relevant clinical or regulatory documents for Theramex products (PSURs, RMP, SmPC, PIL, study protocols, responses to Health Authorities questions etc.);
  • Monitoring PV compliance (eg. ICSRs, periodic safety aggregate reports, safety variations);
  • Preparation of the Theramex Pharmacovigilance system master plan (PSMF);
  • Mentoring junior pharmacovigilance colleagues;
  • Providing training to project teams or at project related external meetings;
  • Case processing activities (data entry, coding, reconciliations, quality control etc.);
  • Negotiation and execution of Pharmacovigilance agreements;
  • Supporting / participating in PV audit and inspections; conducting PV audits as required.

Minimum Requirements (Experience & Education)

  • Bachelor or Master’s degree in science;
  • Extensive experience (over 3 years) in Drug Safety / Pharmacovigilance and global Pharmacovigilance regulations;
  • A proven record of planning and authoring aggregate safety reports (i.e RMPs, PSURs); Excellent medical writing skills;
  • Hands-on and self-reliant and the ability to work independently with diligent attention to detail;
  • Demonstrable multitasking, project management, and execution skills;
  • Ability to work in an environment of rapidly changing priorities and workload; ability to manage multiple activities and assignments;
  • Ability to work both as a member of a team and in an independent, self-directed manner;
  • Ability to communicate effectively in English both orally and in writing.
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    Warsaw • Warszawa, Mazowieckie, Poland