A career with EMD Serono is an ongoing journey of discovery: our 52,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others. EMD Serono is a business of Merck KGaA, Darmstadt, Germany.
The focus of Global Patient Safety (GPS) Innovation is on providing integrated strategic safety expertise to our pipeline products.
The role of the GPS Senior Medical Director/Lead Global Patient Safety Physician within GPS Innovation is to ensure the continuous management of the safety profile for assigned products in clinical development, allowing efficient risk management, proactive risk minimization measures, and the contribution to ongoing evaluation of the benefit-risk profile.
The role includes the delivery of an integrated strategic senior medical and safety expertise to clinical development programs and proactive pharmacovigilance with rapid identification and analysis of safety signals, to define emerging drug safety profiles for assigned products and drive patient risk management.
It is likely that the GPS Senior Medical Director/Lead Global Patient Safety Physician will have a scientific leadership role for a development compound of high medical or business strategic importance.
Who you are:
- Bachelor’s degree with 15 plus years of experience, master’s degree with 10 plus years of experience, and PhD degree with 8 plus years of experience
- Medical degree (MD) or international equivalent with accredited residency strongly preferred
- Accredited fellowship and/or clinical experience in relevant therapeutic area is strongly preferred
- Minimum of 10 years’ experience in the pharmaceutical/biotechnology industry strongly preferred
- Minimum of 8 years’ relevant drug safety and pharmacovigilance experience including training strongly preferred
- Prior experience with NDA/BLA or equivalent regulatory submissions desired
- Excellent medical judgment in safety decision making desired
- Comprehensive mastery of global regulatory requirements for drug safety and pharmacovigilance desired
- Thorough and current clinical knowledge of therapeutic area(s), patient population(s), and drug class
- Excellent proficiency in signal detection and evaluation as well as benefit-risk management desired
- Excellent communication skills, specifically in written and oral presentations
Position requires both domestic and international travel up to 15% of time.
This role can be located at our Rockland or Billerica, MA, location.
What we offer: With us, there are always opportunities to break new ground. We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!
Curious? Apply and find more information at https://jobs.vibrantm.com
The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law. This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.