Posted on: 2019-09-26

Job type: Permanent

Sector: Pharmaceutical and Healthcare

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Mylan offers you a unique opportunity to build a Pharmacovigilance (PV) function and processes and work for a global healthcare company with a broad portfolio covering generics, original products and parapharmaceuticals. Up to now, Pharmacovigilance has been outsourced, but because of a wish to strengthen the internal knowledge-base, Mylan wishes to insource and have the competencies inhouse.

Mylan Denmark & Iceland has their headquarters in Denmark, where 45 engaged colleagues deliver sales, marketing, logistics etc. This role is part of and report to the Head of Regulatory Affairs & PV. As Senior Specialist, you will be functionally head for the PV function and collaborate closely with a PV Specialist. The department is relatively newly established, and works out of Mylan’s new office facilities in Ballerup.

The job
It is a key role for the implementation and maintenance of the Mylan PV system in Denmark and Iceland and supportive to the Nordic PV system as a whole. Besides PV, the function also supports medical information with questions that are escalated to Mylan from the customer service center. Documentation and governance are in place, and this role is expected to define the framework within which PV is expected to operate. Some of the responsibilities include:

• Review, rank, verify, process and document case-related information and ensure handling of Individual Case Safety Reports.
• Ensure record retention of all PV related data and documents according to Mylan Global requirements and national requirements.
• Ensure GDPR and Data Privacy compliance for PV.
• Be the key Affiliate contact for both internal PV audits and regulatory authority PV inspections.
• Monitoring Affiliate PV System performance and compliance and reporting monthly to Global PV functions.
• Maintains compliance with local agreements, including reconciliation and safety data exchange between partner companies.
• Ensure that local processes, procedures and systems are in place for Individual Case Safety Report (ICSR) management including receipt, documentation, forwarding to Global PV Operations, tracking, follow up, etc..
• Collaborate with other relevant functions to maintain Periodic Safety Reporting.
• Administer local PV agreements and Safety Data Exchange Agreements (SDE).
• Organize PV training activities for new Affiliate employees.

Success criteria are to establish a well-operating PV function that reacts in due time and delivers according to expectations, combined with the ability to cooperate successfully across all functions of the organization.

The profile
The ideal candidate has a background as MD, M.Sc. Pharm. or a Nurse or Pharmaconomist with extensive insight in adverse events in pharmaceutical products. Your 6+ years’ professional experience incl. experience from a similar role and perhaps supplemented with experience from regulatory affairs. Most importantly, you have project management experience and either people management experience or a motivation to have it. You are skilled in IT / data systems and are native in Danish and with a high proficiency level in English.

As a person, you demonstrate strong interpersonal skills, where you are robust while also being easy going and good-humored. It comes natural to you to take the lead, make an influence and deliver a high level of service. You combine your independence with being a team-player, who can motivate and engage your surroundings. Your approach to work is characterized by being analytical and systematic, and where you deliver with high precision. You can communicate effectively at all levels and present complex and/or new ideas with clarity and simplicity

Why this role
This is an exciting and challenging role, where you will be part of a growing and speedily developing company, where there is room for making business and success. Because this role is newly established and PV in Mylan is new, you get many opportunities to develop professionally as well as personally. The environment is international and highly dynamic, including collaboration with international colleagues and external partners.

Contact information
please contact Senior Search Consultant Annette Timmermann from Hudson at phone: +45 70 27 77 33. Hudson is the agency handling the selection.

Please send your application in Danish and your resume in English to as soon as possible. Please mark your application with 919.

Please note that by applying through Hudson, you accept our privacy policy and that we keep your papers after the recruitment has been closed. Should you wish to have your data deleted, please write to us on stating your purpose.

About Mylan
If you want to be part of a global health care company that is making a difference and changing lives, Mylan may be the place for you. With a workforce of more than 40,000 worldwide, we can make a difference. We encourage you to visit to learn more about our unconventional culture, our approach to doing business and how we plan to set new standards in health care.

Mylan offers competitive salary, excellent benefits and an environment conducive to professional growth and advancement. All qualified applicants will receive consideration for employment without regard to their disability or protected veteran status. Mylan is an Equal Opportunity Employer, Minorities/Female/Disabled/Veteran.





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