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 Pharmacovigilance Manager role will make an impact:
Key responsibilities for this role include:
- Be the main responsible person for the day-to-day pharmacovigilance activities: individual case safety report management, PSUR submission cooperation, archiving, implementation of any local risk minimisation measures, management and fulfilment of pharmacovigilance agreements, maintenance of updated local Standard Operating Procedures (SOPs) in line with Global processes and applicable regulations, training of the affiliate employees and service providers as applicable, etc.
- Organize, manage and maintain a highly compliant Pharmacovigilance (PV) system for Viatris in Finland.
- 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 PV external service providers in Finland.
- Ensure PV business continuity and out of hours availability process.
- Act as main contact point for the Finish Health Authorities with regards to PV matters and inspections.
- Lead and coordinate internal and external PV audits and inspections.
- Monitor affiliate PV system performance and compliance.
- Manage the local PV budget.
- Cooperation with the Global PV teams as requested or needed.
The minimum qualifications for this role are:
- Medical, Pharmacy or Life Sciences degree (or equivalent).
- Minimum three years of working experience within the pharmaceutical industry and minimum two years within pharmacovigilance.
- Very good knowledge of global Pharmacovigilance regulations, including one or more countries with excellent understanding of local, international and any other relevant legislation with regards to PV (e.g. ICH, CIOMS) in order to fulfill regulatory requirements for Pharmacovigilance.
- Knowledge in European and Finish pharmacovigilance regulations required, and in cosmetovigilance, medical device vigilance and food supplements vigilance highly beneficial.
- Demonstrated ability to provide quality work using strong organisational, facilitation and interpersonal skills in a cross-functional team locally, within PV and externally.
- Skilled at people management including overseeing and controlling outsourced vendor activities in a compliance/regulated field.
- Excellent written and spoken English and Finnish.
- Highly analytical with the ability to give attention to detail.
- Excellent organizational skills and capable of working efficiently.
- Possess an excellent interpersonal, verbal, and written communication skills.
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.
Please send your CV and application to Robert.Toth@viatris.com