Mylan Healthcare GmbH, Hannover
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.
For our Medical PV Team in Hannover we are looking for a new and motivated Team member.
As a Medical Reviewer and Senior Drug Safety Specialist, you will be working in an international global team and act as a cross-functional Medical PV Expert to ensure safety of Mylan’s product portfolio and on a global scope.
The following tasks are expected:
- Representative towards governmental agencies and other competent authorities related to Pharmacovigilance topics
- Responsibility and accountability for the safety of assigned products in the innovator- and complex generics-field including biologics
- preparation of Periodic Reports (PSURs, ACOs, DSURs, etc)
- Active contribution in Risk Management Plan (RMP) related activities including but not limited to RMP writing and medical review, implementation of risk minimization measures and evaluation of effectiveness of same, handling of assessment reports/requests from competent authorities with respect of timelines and applicable obligations.
- perform analyses of patient data including scientific literature
- Active contribution in tasks related to signal management (detection, evaluation and assessment)
- Preparation of Medical Risk Assessments (MRAs) for various labelling, packaging and quality issues
- development/maintenance of the company Reference Safety Information (RSI) in liaison with Reg. Affairs as well as answer to global authority requests.
- Provision of guidance, training and expertise to team members and any other Mylan personnel in medical aspects of drug safety
- Development and update of Standard Operating Procedures (SOP)
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:
- Master’s degree or Diploma as Pharmacist, Physician, Veterinarian
- 3-5 years’ industry experience in PV, Pharmacology/Toxicology, Medical Affairs or Clinical Development
- Broad and proficient understanding and experience in global PV in the pharmaceutical industry or academia or equivalent
- Experienced professional operating within the international arena and working across functional areas
- Excellent time management skills and must be able to work to tight timelines
- Strong organizational and project management skills
- Good negotiating skills, tact and diplomacy. Advanced knowledge of standard business procedures including project management
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. Mylan is an Equal Opportunity Employer.
Interested? Please send your complete application documents in English to firstname.lastname@example.org
Klingt das nach einer Perspektive? Dann bewerben Sie sich!
Bitte beachten Sie: Wir wertschätzen Ihre wertvolle Zeit und bitten Sie deshalb, sich ausschließlich auf ausgeschriebene Stellen zu bewerben. Danke für Ihr Verständnis.
Please note: We appreciate your valuable time therefore ask you to apply only for open vacancies. Thank you for your understanding.
Mylan Healthcare GmbH
Frau Louisa Gabelmann
61352 Bad Homburg v. d. Höhe