Head Global Patient Safety US
EMD Serono

A career with EMD Serono is an ongoing journey of discovery: our 58,000 people are shaping how the world lives, works and plays through next generation advancements in Healthcare, Life Science and Electronics. 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.

United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.

This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the US.

Your Role:As the Head of the Global Patient Safety (GPS) US you are accountable for overseeing all safety tasks in the United States. You ensure full compliance with all global and local regulatory requirements and company standards for safety data management and reporting, for innovative products in development as well as in the launch- and post-marketing phases. You enable swift communication of product-specific safety information between the US and other GPS functions globally to achieve effective safety risk mitigation and optimization of the benefit-risk profile of ourproducts. As a senior PV professional with a proven track-record of health authority interactions and successful product launches, you lead and develop the team of PV professionals in line with the mission of GPS. You continuously monitor the evolving regulatory landscape and ensure that all emerging requirements are met in an efficient manner and in alignment with global standards and industry best practices. You actively network with cross-functions to maintain a high awareness and prioritization of PV aspects in the daily work.You are a valued member of local (extended) leadership teams in R&D in the US and contribute to PV-related decisions in alignment with GPS.

Who You Are:

Minimum Qualifications

• Bachelor's degree in Bioscience,medical doctor, pharmacist, bioscientist, or similar qualification to be decided on individual basis
• 10+years of professional experience; experience in the pharmaceutical industry (5+ years) in an affiliate setting preferably as local responsible for patient safety
• Track record of leading and developing a local/regional PV organization
• Experience in handling contract partners and PV vendors
• Excellent communication in English (written and spoken)

Preferred Qualifications

• Medical degree with experience with managing patient safety in US affiliate
• Previous experience with post-marketing Drug Safety related FDA Inspections
• People manager experience of 5+ years

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.

Job Requisition ID: 220502

Location: Rockland

Career Level: E - Professional (10+ years)

Working time model: full-time

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