Senior Pharmacovigilance Officer - Hatfield, United Kingdom - Viatris
Description
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.
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.
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.
The Role & What You Will Be Doing
Viatris is the 2nd largest pharmaceutical company in the world and has a complex and a comprehensive portfolio of over 1500 active ingredients within pharmaceutical and biosimilar product range and spans across therapeutic groups.
Senior Drug Safety Specialist role within Global Safety Surveillance and Risk Management entails providing global pharmacovigilance support to Mylan products worldwide in accordance with Company, international standards and regulatory requirements, as assigned.
- Preparation and production of global periodic safety regulatory reports including PSURs, PBRERs, DSURs, Addendum to Clinical Overviews and ad-hoc safety reports required for submission to Health authorities worldwide.
- Preparation, production and management of global Risk Management Plans.
- Performing Global Signal Management for Mylan products across the globe.
- Identification of new safety information published or communicated by Health Authorities worldwide in line with Mylan's Safety Trigger Monitoring process.
- Support in development of Global Company Core Data Sheet (CCDS) and production of Global Reference Safety Information.
- Support and response to questions raised by Health Authorities worldwide.
- Conducts or leads with guidance, the discussion and management of safety issues and presentation of findings to Mylan governance bodies.
- Support and provide guidance regional and local PV teams within Mylan
- Liaise and support global, regional and local Regulatory, quality, medical affairs, clinical research, commercial, affiliated companies and Mylan drug safety in performance of the above mentioned tasks.
- Participates in project focused meetings and provides safety expertise along with safety physicians.
- Graduate or post graduate in pharmacy/health sciences.
- 23 years 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.
- Excellent career progression opportunities
- Worklife balance initiatives
- Bonus scheme
- Health insurance
- Pension
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 visitSustainability 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 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.
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