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.