1478 Generics [U.K.] Ltd.
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 Drug Safety Physician, Safety Surveillance & Risk Management role will make an impact:
Key responsibilities for this role include:
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 Central & Local Regulatory & PV Departments, Operations, affiliated companies and Viatris drug safety in performance of the above mentioned tasks
Assists in any other Pharmacovigilance / Medical Information 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
The minimum qualifications for this role are:
Experience working within pharmacovigilance 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
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.