PV Officer (Pharmacovigilance Operations)

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: · Assist in retrospective quality review of individual case safety reports (ICSRs) stored in the global drug safety data base to ensure quality/ consistency in line with Mylan convention. · Creation and update of pharmacovigilance Operations process convention document(s) and training materials · Support in the management of Pharmacovigilance Operations projects. · Assist in answering queries in relation to Pharmacovigilance Operations processes. · Review of changes to legislations concerning pharmacovigilance. · Management of Global Pharmacovigilance Operations CAPAs to ensure CAPAs identified and closed within the agreed timelines. Maintain the CAPA status tracker & Provide regular status updates to managers and the Quality Management team. Assist with audits/ inspections preparations and request as required. (For entry into Qualifications area) 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: · Life science degree · The ability to evaluate, analyse and interpret complex information · Positive approach to assigned tasks, with proven abilities in time management · Excellent interpersonal and communication skills (both written and oral) · Self-motivated, adaptable to a dynamic drug development environment · Able to collaborate effectively with cross-functional team members, and external partners · Proficiency in MS Outlook, Word, Excel, and PowerPoint · Flexibility to perform other duties as assigned Why 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 35,000 worldwide, we can make a difference. We encourage you to visit Mylan.com 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. This job was originally posted as www.totaljobs.com/job/89961285