Vigilance & Safety Officer (Medical Device)

9145 Meda Pharma S.p.A.
- At VIATRIS, we see healthcare not as it is but as it should be. We act courageously and are uniquely positioned to be a source of stability in a world of evolving healthcare needs.
Viatris empowers people worldwide to live healthier at every stage of life.
We do so via:
Access - Providing high quality trusted medicines regardless of geography or circumstance;
Leadership - Advancing sustainable operations and innovative solutions to improve patient health; and
Partnership - Leveraging our collective expertise to connect people to products and services.

Every day, we rise to the challenge to make a difference and here’s how the Safety & Vigilance Officer (Medical device) role will make an impact:

- Key responsibilities for this role include:

- Managing Individual Case Safety Reports (ICSRs) of the Company coming from the ASR (Medical Devices, Food Supplements and Cosmetics). Checking ICSRs data for consistency and accuracy triggering follow-up requests to ASR if needed. Recording ICSRs in the Global Safety Database (Argus): Data Entry and Quality Check. Advising and communicating to Safety and Vigilance Manager the possibility to report a case to the Health Authority.
- For Medical Device/In Vitro Diagnostic Products: Assessing listedness of ICSRs of non-company medical devices and ensure submission to Partner.
- Performing ICSRs reconciliations periodically with affiliates (backup)
- Managing of Data Entry Vendor (periodical reconciliation, agreement revision, training, invoices check and archive)
- Writing or reviewing Standard Operating Procedures of the Vigilance and Safety System, where appropriate
- For Medical Device/In Vitro Diagnostic Products: Draft of Clinical Evaluation Plans and Reports to be entered in the Technical Files
- For Medical Device/In Vitro Diagnostic Products: Draft of PSUR/Post Market Surveillance Report
- For Medical Device/In Vitro Diagnostic Products: Writing preliminary safety assessments for R&D projects and for product changes of the marketed products, according to the relevant regulation(s)
- For Medical Device/In Vitro Diagnostic Products: Performing safety literature screening on Affiliates products as per in-place agreements
- For Medical Device/In Vitro Diagnostic Products: performing annual active surveillance as per current Company procedures
- For Medical Device/In Vitro Diagnostic Products: Answering to product queries received from customers or affiliates
- The minimum qualifications for this role are:

- Minimum Bachelor’s Degree in Scientific Disciplines (MD, Pharmacy or similar) and a relevant experience in Pharmacovigilance activities, or Medical Device Regulatory Affairs or Medical Device Quality Assurance. However, a combination of experience and/or education will be taken into consideration
- Proficiency in speaking, comprehending, reading, writing English and Italian is required.
- Ability to write comprehensive reports and detailed business correspondence.
- Ability to communicate ambiguous concepts and to present to groups across the organization.
- Must possess analytics and decision-making ability, speed and autonomy in working.
- Teamwork and cooperation. Good relationship and networking; ability to solve problems with complex variables through non-standardized solutions that require independent judgment and analysis;
- Good knowledge of Microsoft office Tools
- Argus Safety knowledge will be an asset.
- Our Office is based in Monza, San Fruttuoso area.
- At Viatris, we offer competitive salaries, benefits and an inclusive environment where you can use your experiences, perspectives and skills to help make an impact on the lives of others.
- Viatris is an Equal Opportunity Employer.