Posted on: 2019-05-09

Job type: Permanent

Sector: Pharmaceutical and Healthcare

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to Mylan - Ballerup

Mylan offers you a unique opportunity to be part of a newly established Pharmacovigilance (PV) unit, where you, can take active part in implementing and executing PV processes, while working for a global healthcare company with a broad portfolio covering generics, original products and parapharmaceuticals. Up to now, PV has been outsourced, but because of a wish to strengthen the internal knowledge-base, Mylan wants 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 the PV team and reports to the PV Manager, and is part of the Regulatory Affairs (RA) and PV department. The department is relatively newly established, and the whole company will per June 11th move to new office facilities in Ballerup.

The job
As PV Specialist, you work closely together with the PV Manager in building frameworks and executing on PV processes. 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 ensure deliveries and timely responses. Some of the tasks include:

• Ensure handling of Individual Case Safety Reports and Periodic Reports according to Mylan Global requirements and national requirements.
• Review, rank, verify, process and document case-related information.
• Determine and perform appropriate case follow-up, including generation of follow-up requests.
• Determine reportability of scheduled reports, ensuring adherence to regulatory requirements.
• Assist in handling signal detection, safety issues, risk management activities and product alerts.
• Liaise with key partners, locally, and other stakeholders regarding safety data collection and data reconciliation.
• Develop and maintain Pharmacovigilance and Medical Information Standard Operating Procedures.
• Support the internal PV audits and regulatory authority PV inspections with information and assistance.
• Act as PV Manager Deputy in the absence of the PV Manager.
• Training of employees in PV and Medical Information.
• Handle Medical Information enquiries in accordance with local legislation and company guidelines.

Success criteria are to ensure PV deliverables according to internal governance and compliant with established procedures, and to participate in building well-established PV processes.

The profile
The ideal candidate has a background as M.Sc. Pharm., Nurse or Pharmaconomist with insight in adverse events in pharmaceutical products. Your 2+ years’ professional experience incl. experience from managing PV processes and perhaps supplemented with experience from regulatory affairs. Most importantly, you take a strong interest in PB, and perhaps has a motivation for working broader than what is possible in the big pharma companies. You are skilled in IT / data systems and are native in Danish and with a good 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 deliver a high level of service and quality. You are a team-player, supportive to your colleagues, and one who appreciate to have your own tasks to solve independently. Your approach to work is characterized by being analytical and systematic, with strong attention to deadlines. 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 920.

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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