Director Safety Surveillance & Risk Management (12 months fix term contract)

Generics [U.K.] Ltd.

Viatris is a global healthcare company uniquely positioned to bridge the traditional divide between generics and brands, combining the best of both to more holistically address healthcare needs globally. With a mission to empower people worldwide to live healthier at every stage of life, we provide access at scale, currently supplying high-quality medicines to approximately 1 billion patients around the world annually and touching all of life's moments, from birth to the end of life, acute conditions to chronic diseases.

We have been included on a number of award lists that demonstrate the impact we are making.

Our global portfolio includes best-in-class, iconic brand-name products as well as global key brands; generics, including branded and complex generics; and other offerings across a wide range of therapeutic areas. We are committed to helping create healthier communities worldwide through education, outreach and better access to treatment.

For those driven to live their lives with purpose, Viatris helps employees realize their full potential by creating a collaborative culture that fosters courage and resilience. Viatris is more than just a place to work. This is a place to make a difference in the world.

The Role & What You Will Be Doing

Every day, we rise to the challenge to make a difference. Director, Safety Surveillance and Risk Management is to assist in the global pharmacovigilance activities within global PSRM for Viatris in accordance with Company, international standards, and regulatory requirements, as assigned.

Here’s how the Director, Safety Surveillance & Risk Management role will make an impact:

• Act as Medical Safety Expert for the assigned Viatris medicinal products
• Responsible for coordinating 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 coordinating 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.