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US Patient Safety Team Lead

Millipore Corporation

This is a Full-time position in Rockland, MA posted June 8, 2021.

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. 
Your Role:
The US Patient Safety Team Lead (US TL) is responsible to ensure full compliance with all relevant global and local regulatory requirements, internal company standards and best practices for pharmacovigilance (PV) in the pharmaceutical industry.

Is accountable for coordinating and implementing pharmacovigilance best practices by US Patient Safety.

Also, US TL  is accountable for successful project execution including definition of milestones.  The US TL should have detailed knowledge and understanding of the local regulatory pharmacovigilance requirements for the US.

US TL is responsible for managing the team of Patient Safety Associates and Specialists, ensuring optimal process efficiency, maintenance of excellent team work and delivery of Key Performance Indications.

This person will be responsible for creation of corrective and preventative action plans (CAPAs).

Who You Are :

Minimum Qualifications
BS degree in science, healthcare of equivalent field Must have a professional healthcare background 5+ years of pharmacovigilance experience in an affiliate setting
Preferred Qualifications
Medical doctor, nurse, pharmacist, bioscientist or similar qualification 3+ years of experience managing operations team in pharmacovigilance Previous experience in receiving FDA Inspection Knowledge of FDA Individual Case Safety Report reporting guidelines
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.