Medical Pharmacovigilance Expert
Jefferson Wells, on behalf of an Italian pharma company, is looking for a Medical Pharmacovigilance Expert.S/he will be responsible for the following pharmacovigilance activities, primarily (but not exclusively), assigned to her/him:
- Medical review contribution to Serious Adverse Events (SAEs)/Individual Case Safety Reports (ICSRs) assessment, and Follow-up request together with other PV-Operations team members
- Review of safety cases line listing (LL) and preparation of regulatory documents in accordance with ICH/GVP guidelines and company standards (i.e. PSURs, RMPs, Deficiency Letters, etc.)
- Perform proactive and on-going signal detection and risk management assessments to ensure a positive risk-management for the Company's products.
- Support to the development of risk management programs
- Medical review and assessment of safety profiles for Corporate and Local Products, which include CCSIs, SmPCs, and any other product related information document.
- Clinical evaluation of relevant scientific and medical literature
- Report periodic compliance and performance metrics and KPIs to the line manager within the required timelines
- Contribution to the preparation/update of PV standard operating procedures, working instructions and templates
- Preparation of medical education programs to healthcare professionals
- Support the Affiliates in the management of their local products, as appropriate (e.g. ICSR assessment, review/preparation of PSURs, RMPs).
- Assist and participate in Pharmacovigilance audits.
- Assist in Pharmacovigilance Inspection readiness activities.
- Medicine Degree
- Previous experience in the role
- Fluent English