Senior Manager PV Sweden & Affiliate Safety Representative
Viatris · Solna
Mylan ABViatris 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 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, and here’s how the Senior Manager PV Sweden & Affiliate Safety Representative role will make an impact:
Organize, manage, and maintain a highly compliant Pharmacovigilance (PV) system for Viatris in Sweden.
Maintain awareness and ensure adherence to established and updated local and global processes and guidelines, as well as national and international regulations and guidelines for pharmacovigilance.
Lead, supervise and coordinate the PV team members and any PV related external service providers in Sweden.
Ensure PV business continuity.
Act as main contact point for the Swedish Health Authorities with regards PV matters and inspections.
Lead and coordinate internal and external PV audits and inspections.
Monitor affiliate PV system performance and compliance.
Plan and manage the local PV budget.
Is the main responsible person for the day-to-day PV activities: Individual case safety report management, PSUR submission cooperation, archiving, implementation of any local risk minimization measure, management and fulfillment of pharmacovigilance agreements, maintenance of updated local Standard Operating Procedures (SOP) in line with Global processes and applicable regulations, training of the affiliate employees and service providers as applicable, etc.
Cooperation with the Global PV teams as requested or needed.
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:
Medical, Pharmacy or Live-sciences degree (or equivalent).
Minimum three years of working experience within the pharmaceutical industry and minimum two years within pharmacovigilance.
Responsible person with management and leadership skills, with high level of autonomy.
Demonstrated ability to provide quality work using strong organizational, facilitation and interpersonal skills in a cross-functional team locally, within PV and externally.
Experienced in working in cross-functional teams and/or global projects, teamwork skills and in virtual.
Excellent written and spoken English and Swedish.
Highly analytical with the ability to give attention to detail.
Excellent organizational skills and capable of working efficiently.
Deep knowledge in European and Swedish pharmacovigilance regulations required, and in cosmetovigilance, medical device vigilance and food supplements vigilance strongly recommended.
Good knowledge of other international Pharmacovigilance regulations and any other relevant legislation with regards to PV (e.g. ICH, CIOMS) strongly recommended.
Skilled at technical writing and authoring, including SOPs/procedural documents, corrective actions plans / exception reports.
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.
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.