Pharmacovigilance Officer, Regulatory Affairs & Pharmacovigilance department

For Us, It’s A Mission

At Mylan, we mean it when we say we work every day to provide access to high quality medicines to the world’s 7 billion people. If you are unconventional, relentless and passionate. If you believe in doing what’s right, not what’s easy. If you are a doer and have a passion for serving others, we want to talk to you.

Make a Difference

At Mylan, each person has the ability to make a difference. From the providers who sell and market our products to the producers who develop and manufacture them and finally to our business partners who support the providers and producers, we all have a mission critical role. Here’s how this role will help:

Overall Job Purpose:

Key role for the Mylan Pharmacovigilance (PV) system in Norway and supportive to the Nordic PV system as a whole.

Main Accountabilities:

• Responsible to organize, implement and maintain the Affiliate PV System
• Ensure after-hours availability process
• 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 awareness of local PV legislation and of relevant international legislations, regulations and guidelines.
• Maintains compliance with local agreements, including reconciliation and safety data exchange between partner companies.
•  Complete monthly ICSR reconciliation with interacting functions and/or departments, including medical information, product complaints.
• 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
• Contribute to the maintenance of the PSMF
• Ensure PV business continuity
• Administer local PV agreements and Safety Data Exchange Agreements (SDE)
• Organize PV training activities for new Affiliate employees.

Make Our Values Your Values

Mylan hires only the best. People who thrive in a culture of innovation and empowerment. People who are active learners and have a positive attitude. People who are leaders and know that by working together we can run faster, reach higher and achieve more. By doing so, we will continue to set new standards in health care. Here are the minimum qualifications and essential functions for this position:

The PV Officer must be able to cooperate successfully across all functions of the organization, and to represent the company externally in the best possible way. Further, qualified candidates possess the below qualifications:

The PV Officer should preferably meet the following professional skills:

• Formal education at MSc level (medicine, pharmacy or other relevant subject within Life Sciences)
• Minimum three years of working experience within the pharmaceutical industry and minimum two years within pharmacovigilance.
• Excellent project management skills
• Able to operate internationally with fluent English

Personal profile:

• Strong interpersonal skills – robust with natural authority, easy going
• Works well in teams and alone
• Service minded; a ‘doer’ – getting things done, also when the pressure is high
• Ability to communicate effectively at all levels and present complex and/or new ideas with clarity and simplicity
• Analytical and systematic

Why Mylan and Pharmacovigilance (PV):

• An exciting and challenging position where the candidate will secure deliverables on time in high quality.
• Mylan is growing, developing speedily – room for making business and success
• Opportunities to develop professionally as well as personally.
• An international and highly dynamic environment, including collaboration with international colleagues and external partners.

Interested or any questions?

Please contact Head of Regulatory Affairs, Peter Boros by phone +47 45 07 33 80 or mail peter.boros@mylan.com

Deadline to apply for the position is April 24, but applicants will be evaluated consecutively.