POSITION SUMMARY:
Reporting to the Regional Pharmacovigilance Lead, this role will assume primary responsibility for ensuring that the benefit-risk assessment of all Menarini products in collaboration with the global and local counterparts. This role is accountable for the Benefit and Risk activities, including but not limited to signal detection, risk management, risk mitigation plans, safety analyses in aggregate reports, and medical review of ICSR.
Within this role, he/she will be supporting in the scientific review of safety-related information in study protocols, study reports, Investigator Brochures, CCDS, product labeling, and aggregate reports.
KEY RESPONSIBILITIES:
- Responsible for the timely management of all adverse event reports for all products (Pharmaceutical, Medical devices, Cosmetics, and food supplements in accordance with the locally approved materials, including medical assessment and adequate follow-up in ARISg Pharmacovigilance Database.
- Responsible for monthly signal management activities for all products, including but not limited to the monitoring of safety profile, signal validation & signal evaluation, and propose appropriate risk management and risk minimization measures in accordance with international standards.
- Responsible for the development/review/provide input to Aggregate Reports (e.g. DSUR, PSUR, PBRER, etc.) and Risk Management Plans (RMP) as required
- Support IDSCUM in the safety review of clinical study documents, including protocols, study reports, clinical safety data analysis, and marketing application components
- Responsible for providing responses to safety-related questions from Regulatory authorities and/or internal/external stakeholders.
- Contribute to process optimization initiatives and, where needed, set up new process flow/activities.
- Support in product information (e.g. SmPC, PIL, etc.) review and harmonization
- Responsible for the review of identified safety publications from the literature surveillance
- Participate in the preparation, review, and maintenance of Regional Pharmacovigilance Standard Operating Procedures, Working Instructions, and Forms
- Supports PV audits and inspections, including readiness activities, and supports other audits/inspections, including the development and following up of CAPAs (with country) in response to findings/observations.
- Participates in and supports audits of contractual partners/vendors as necessary.
KEY REQUIREMENTS:
- Medical Degree with at least 2 years of pharmacovigilance experience in the CRO/Pharmaceutical industry.
- Familiarity with electronic safety databases (ARISg, ARGUS), and coding dictionaries (MedDRA, DS Navigator, Medidata Coder) is preferred.
- Good baseline knowledge of scientific literature retrieval and valuation (mainly using PubMed and Medline)
- Sound knowledge of general medicine and clinical practice, and the ability to assess the clinical relevance of medical data and to interpret its clinical meaning.
- Excellent clinical judgement and ability to articulate complex clinical issues in a scientifically sound and understandable way.
- Strong verbal and written communication skills
