Director Safety Surveillance and Risk Management in Hatfield

Location: Hatfield, England, United Kingdom

Time type: Full time

The Role & What You Will Be Doing

• Act as Medical Safety Expert for the assigned Viatris medicinal products.
• Responsible for co-ordinating Periodic Safety Update Reports (PSUR) and Addendum to Clinical Overview (ACO) related activities (including but not limited to PSUR writing & medical review, handling of requests received from Central & Local Regulatory Affairs and PV departments) within respect of timelines and any other related task.
• Responsible for co-ordinating Risk Management Plans (RMP) related activities (including but not limited to collection of data, RMP writing and medical review, handling requests received from central or local regulatory affairs and PV department) within timely manner.
• Responsible for Signal Management related activity (including signal detection by company methodology, medical review of signalling reports, communication and escalation to CPSC).
• Responsible for assisting in CCDS development, review and updating, Maintenance of RSI, Health Authority Responses.
• Assists in preparing or prepares responses to Regulatory Authority questions related to safety issues and conducts medical review.
• Provides safety input into Medical Risk Assessments (MRAs), drives the process from SST and develops and follows-up the quality issues having safety implications.
• Reviews and provides medical/safety inputs in the Product Information and labelling issues.
• Liaises with internal and external stakeholders in performance of the above mentioned tasks.
• Assists in any other Pharmacovigilance department projects, as necessary.
• Provides medical safety expertise and training to other personnel, as necessary.
• Keeps current with professional and pharmacovigilance regulations and knowledge.
• Provides medical guidance to PV Officers/ Senior PV Officers in medical aspects of drug safety and any other Viatris personnel.
• Writing & update of Standard Operating Procedures (SOP).
• Assists or oversees any other project where PSRM SST is involved, as deemed necessary.

About Your Skills & Experience

• M.B.B.S/MD/BDS or equivalent medical degree.
• Extensive years of experience within pharmacovigilance as a drug safety physician is preferential.
• Excellent time management skills and must be able to work to tight timelines.
• Ability to manage own workload and interact well in a team environment.

Benefits at Viatris

• Top Employer Accreditation, demonstrating that we provide excellent people policies and practices.
• Competitive compensation package inclusive of annual bonus.
• Focus on career progression with growth and development opportunities.
• Hybrid working.
• Emphasis on Health & Wellness programmes.
• 100% paid medical insurance and Employee Assistance Programme.
• Life cover.
• Excellent employer-matched pension scheme with Viatris contributing up to 11%.
• 2 paid volunteer days per year.

Viatrus is an Equal Opportunity Employer.