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.
Mylan N.V. (NASDAQ: MYL) and Upjohn, a division of Pfizer, today unveiled the logo and branding for VIATRIS™, the new company that will be formed by combining Mylan and Upjohn. The combination will provide Viatris with a portfolio of 1,400 molecules across many different therapeutic categories and dosage forms, a global reach across more than 165 countries and territories, and a worldwide workforce of 45,000 with vast expertise in science, manufacturing, quality, regulatory and medical affairs. See more www.mylan.fi .
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 we are looking to Mylan Finland Oy/Viatris (location Espoo) more professionals who will make an impact. Are You our new
Key responsibilities for this role include:
- 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 PV matters and inspections.
- Lead and coordinate internal and external PV audits and inspections.
- Monitor affiliate PV system performance and compliance.
- Manages and the local PV budget.
- Is 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 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.
To succee in this role You have
- 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.
- Possess an excellent interpersonal, verbal, and written communication skills.
- Skilled at people management including overseeing and controlling outsourced vendor activities in a compliance/regulated field.
- Respected influencer across multiple stakeholders and skilled at managing across functional matrices and geographical boundaries/cultures; seen as an active and collaborative partner at all levels of the organization
- Experienced in working in cross-functional teams and/or global projects, teamwork skills.
- Experienced in working in virtual team.
- Proven track record at successfully working in a face-paced environment
- 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.
- 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), as well as Viatris corporate and local systems (e.g. Global Safety Database, local data bases) and procedures, in order to fulfill regulatory requirements for Pharmacovigilance.
- Computer literacy (Windows, MS Office)
- Able to research, compile and provide safety information in a clear concise manner.
- Skilled at technical writing and authoring, including SOPs/procedural documents, corrective actions plans / exception reports.
- Proven track record of proactively identifying, assessing, and effectively managing c ompliance risks
- Knowledge in European and Finish pharmacovigilance regulations required, and in cosmetovigilance, medical device vigilance and food supplements vigilance strongly recommended.
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 notice fluent Finnish language is important requirement.
Leave Your application and CV latest 06.08.2021 via following link.
More information Senior Consultant, headhunter Jukka Mustonen, email email@example.com, phone +358 504348140.
Hakuaika alkaa: 09.07.2021 12:00Hakuaika päättyy: 06.08.2021 23:55