PV Officer - 1 year contract - Warsaw
PV Officer - 1 year contract - Warsaw
Posted on :
26-06-2025
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1 Vacancy
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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 Masters 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.
Employment Type
Full Time
Key Skills
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