- 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
- 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.
- Provides medical safety expertise and training to other personnel, as necessary
- 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)
- Employees, who will initiate customer engagement programs are regarded as the responsible person for the activity and are - as per definition in the applicable SOP - the program owner. The program owner must comply with the following before the start of the activity: complete training on customer engagement activity-related procedures and guidance documents. initiate the PV Assessment of the activity by involving the Affiliate Safety Representative ensure relevant pre-requisites are implemented and communicated to the customer engagement team
- M.B.B.S/MD/BDS or equivalent medical degree.
- 2 years pharmaceutical experience working 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.
- 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
Manager Safety Surveillance - Hatt, United Kingdom - Viatris
Description
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.
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 realise 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 and here's how the Manager, Safety Surveillance & Risk Management role will make an impact:
Main Accountabilities and responsibilities (but not limited to):
About Your Skills & Experience
For this role, we're looking for a candidate who has an effective combination of the following qualifications, skills and experiences:
At Viatris, we are dedicated to building a truly diverse, inclusive and authentic workplace, so if you're excited about this role but your past experience doesn't fully align with every requirement, we still encourage you to apply. You may just be the right candidate for this or other roles.
Benefits at Viatris
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. Some of our benefits include the following on top of a competitive salary:
Diversity & Inclusion at Viatris
At Viatris, diversity and inclusion are essential to our mission. The diversity we foster in all aspects of our business can be one of our greatest strengths in redefining healthcare not as it is, but as it should be. If you would like to know more about what diversity, equity and inclusion means to us, please visit
Sustainability at Viatris
Corporate social responsibility is fundamental to the Viatris mission. We work to advance responsible and sustainable operations and leverage our collective expertise to empower people to live healthier at every stage of life, recognizing that our actions affect the stakeholders and communities we serve. To learn more about our efforts, please visit
At Viatris, we offercompetitivesalaries, benefitsandan 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.