Associate Director US Safety Compliance

Posted 11 Jun 2019

Rockland, Massachusetts - United States

Req Id 191321



A career with EMD Serono is an ongoing journey of discovery: our 51,000 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.


Healthcare professionals and FDA and locally provides cross functional support to EMD Serono US. Patient safety US is fully integrated into Global Patient Safety Regions organization nested within with Global Patient Safety.


Your role:

To establish and maintain quality-assured, compliant, and comprehensive systems within Patient Safety US that are well-integrated with Global Patient Safety and EMD Serono, Inc functions and provide structure and processes to monitor activities. To establish and ensure implementation of safety standards for US commercial and medical organization programs in alignment with US and global adverse event requirements. To ensure systems and standards are aligned with EMD Serono, Global Patient Safety and global quality and compliance requirements and are consistent with applicable US and global regulations.


Who you are:

You are an enthusiastic and detail oriented professional having extensive industry experience with medical, pharmaceutical or healthcare organizations or relevant working experience. You are extremely organized a good communicator who leads/manages projects and a strong contributor and innovator.


  • Bachelor’s degree with 8+ years of experience, master’s degree with 3+ years of experience, or PhD degree in a medical, pharmaceutical, healthcare or related field required
  • Health Care Professional (HCP) preferred
  • Experience and solid working knowledge of FDA and Global Pharmacovigilance regulations and guidance’s
  • Experience and ability to manage oversight over a quality management system, including compliance and training
  • Experience with audits and inspections, backroom or front room experience, FDA inspection experience preferred.
  • Experience with Pharmacovigilance Master file organization preferred
  • Experience managing the Deviation and Correction Action Preventative Action (CAPA) processes for US Safety office

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


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.

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