Manager, Safety Surveillance and Risk Management
Postuler locations Hatfield, England, United Kingdom time type Temps plein posted on Offre publiée aujourd'hui job requisition id R5655560 Generics [U.K.] Ltd.
Chez Viatris, nous envisageons la santé non pas telle qu'elle est mais telle qu'elle devrait être. Nous agissons avec courage et notre positionnement unique est source de stabilité dans un monde où les besoins en matière de santé sont en constante évolution. Viatris permet à chacun dans le monde entier de vivre en meilleure santé à chaque étape de sa vie.
The Role & What You Will Be Doing
Every day, we rise to the challenge to make a difference. Manager, Safety Surveillance and Risk Management within Global PSRM entails providing global pharmacovigilance support for activities within Global PSRM for Viatris in accordance with Company, international standards and regulatory requirements, as assigned.
Here’s how the Manager, Safety Surveillance & Risk Management role will make an impact:
* Responsible for Global Periodic Reports related activities.
* Responsible for Global labelling activity, including review of SPC/PIL for safety information, Product information verification, Labelling remediation project, Training of team members.
* Overall responsibility of CCDS/RSI development, review, and updating.
* Overall responsibility of Global Risk Management Plan and Global Signal Detection.
* Overall responsibility of Global safety triggers (i.e Regulatory intelligence, Detection, and review of safety triggers, ensure that all the requested action is completed and TWCC are raised).
* Liaises with Global & Local Regulatory & PV Departments, Operations, affiliated companies and Viatris drug safety in performance of the above-mentioned tasks.
* Provides medical safety expertise and training to other personnel, as necessary.
* Provides guidance to senior/drug safety technical assistants, senior/drug safety specialist and medical reviewers in various aspects of drug safety and any other Viatris personnel.
* Assists or oversees any other project where Global PSRM SST is involved, as deemed necessary.
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:
* MBBS/MD or equivalent medical degree is required.
* Extensive years of experience working in pharmacovigilance.
* Previous experience leading a team.
* 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
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:
* 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.
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.
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.
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