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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.

Warsaw • Warszawa, Mazowieckie, Poland