Associate Director, Deputy Local Patient Safety Officer

Work Your Magic with us!

Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.

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.

New Boston- Seaport location in Summer 2024

Your Role:

As delegated by the Head of Global Patient Safety, US Region Local Patient Safety Officer, this role assumes Deputy functions in the following local affiliate pharmacovigilance (PV) activities where applicable:

• Lead and execute PV operational tasks under the responsibility of the local affiliate
• Manage local affiliate PV department and staff management
• Serve as interim Global Patient Safety representative for the local affiliate in LPSO’s absence
• Maintain and ensure quality and compliance of the Local PV System
• Represent Global Patient Safety as an affiliate representative on local cross-functional teams and activities
• Prepare, manage, follow-up, and actively participate as a subject matter expert in local PV related audits and Health Authority inspections
• Ensure benefit-risk management of all products on the market and under development in the US 
• Support the development, manage and execute the REMS strategy for new programs, ensuring proper oversight and documentation of the REMS program activities 
• Ensure compliance and oversee that all other applicable core PV activities or processes in the local affiliate are completed in a timely manner with high quality

Location: Billerica, MA & New Seaport location in Summer 2024 Hybrid

Who You Are:

Minimum Qualifications:

• Bachelor's Degree with 5-8 years of experience, or master's degree with 3-6 years of experience or PH.D with 2-5 years of experience.

• Advanced Pharmacovigilance activities

• Pharma industry/health authority (i.e. Clinical Research, Medical or Regulatory affairs)

Preferred Qualifications:

• Advanced Degree, health care or life sciences
• Ability to lead without authority.
• Strong leadership skills/ People management
• Excellent collaboration and communication skills

• Local operational knowledge further to Local/regional PV regulations is a desirable

• Strong critical thinking, problem solving, and decision-making ability
• Excellent organizational skills, ability to prioritize tasks, lead strategic projects, and rapidly adapt to changing priorities 
• Strong intercultural and teamworking skills (developed from practical experience)
• Strong project management skills with experience in leading projects critical to the business
• Strategic thinking with excellent ability to interact with stakeholders locally and globally
• Strong ability to interact and influence stakeholders
• In-depth understanding of drug development and life-cycle management performed across different business functions
• In-depth knowledge and comprehension of local PV regulations and requirements, including FDA REMS regulations and guidelines, and awareness of applicable international PV regulatory requirements.

What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!
 
Apply now and become a part of our diverse team!

If you would like to know more about what diversity, equity, and inclusion means to us, please visit https://www.emdgroup.com/en/company/press-positions.html