Pharmacovigilance Officer or Senior PV Officer - 1 year contract

This is a 1 year maternity covercontract.

Job Purpose

Performing an accurate and scientifically sound full data entry in the Theramex
Global Safety database. Provide pharmacovigilance expertise to safety surveillance& risk management compliance; Authoring of PV documents.

The position is part of the Global Theramex Pharmacovigilance Team based in Warsaw HQ.

Key Duties andResponsibilities

Case processing activities including triage and full data entry e.g.seriousness assessment MedDRA coding narrative writing ofreports from post marketing sources onto the global safetydatabase in accordance with company SOPs and regulatory
requirements; MedDRA coding;

ICSRs follow ups ICSRs submission to various Health Authorities;

Performing AE/ SAE reconciliation;

Global Literature review using different tools(eg: Embase) and MLMservice;

EudraVigilance activities including downloading ICSRs(Individual CaseSafety reports) from EudraVigilance and EudraVigilance submissions;

Using and maintaining the globalsafety database;

Performing signal detection and risk management activities underthe guidance of the PV Physician and Senior Team members;prioritising the risks and mitigation actions that provide valuefor patients;

Producing accurate and fitforpurpose aggregated data review andsignal evaluation documents with clear conclusions andrecommendation for actions;

Authoring and/ or reviewing relevant PV or Regulatory documents for Theramex products PSURs RMP RSI (SmPC/PIL) responses to Health Authorities questions etc.; contribution to study protocols;

Contribution towards the preparation of the Theramex PSMF if required;

Supporting / participating in PV audits and inspections if required;

Contributing to the ongoing enhancement ofthe Pharmacovigilance processing and writing Standard OperatingProcedures and Working practices;

Processing PV related deviations and CAPAs(Corrective and Preventive
actions);

Any other duties that can be reasonably added to this role.

MinimumRequirements(Experience &Education)

Bachelor or Masters degree in Life science

Have a relevant drug safety experience (25years) depending on a role

Competent with medical terminology excellent communication abilitiesand possess good IT skills

Previous use of safety databases and EudraVigilance is an advantage

Work independently but also as part of a team

Understanding of GVP modules and European Regulations

A high standard of organization narrative writing and impeccableattention to detail is essential

This is an excellent opportunity for a candidate seeking to develop /broaden their safety knowledge in postmarketing setting and to be a partof the progressive global department

Must be eligible to work in Poland

Ability to communicate effectively in English both orally and in writing isessential