Pharmacovigilance Officer

Pharmacovigilance Officer

Location: Warsaw Poland

We are looking for a Pharmacovigilance Officer who will be responsible for performing an accurate and scientifically sound data entry in the Theramex Globals Safety database. This would be a great opportunity for someone looking to get exposure to different aspects of Pharmacovigilance.

About you:

The ideal candidate will have the following:

• Life science graduate and have relevant drug safety experience.
• Competent with medical terminology excellent communication abilities and possess good IT skills.
• Previous use of safety databases and EudraVigilance is essential.
• Work independently but also as part of a team.
• Understanding of GVP modules
• A high standard of organization narrative writing and impeccable attention 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 part of a progressive department.

About the role:

As a Pharmacovigilance Officer you will be involved in the following activities:

• Case processing including data entry review and assessment AE/ SAE reports (including narrative writing) from post marketing sources onto the global safety database in accordance with company SOPs and regulatory requirements.
• Performing AE/ SAE reconciliation
• MedDRA coding
• Literature review using different tools (eg: Embase) and MLM service.
• EudraVigilance activities including downloading ICSRs (Individual Case Safety reports) from EudraVigilance and EudraVigilance submissions.
• Performing various searches in the safety database to support the preparation of aggregate safety reports signal detection or other PV activities under the instructions of a PV Physician and or/ Senior PV Officer
• Using and maintaining the global safety database
• Contributing to the ongoing enhancement of the Pharmacovigilance processing and writing Standard Operating Procedures and Working practices
• Processing PV related deviations and CAPAs (Corrective and Preventive actions)