US Local Patient Safety Specialists

 

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.

 

Job Title: US Local Patient Safety Specialists

 

Job Location: EMD Serono Research and Development Institute, Inc., One Technology Place, Rockland, Massachusetts 02370

 

Responsibilities:

 

• Handle all local safety information, including collection, registration, and transmission to GDS as applicable in a timely manner;
• Oversee vendor handling of local safety information including collection, registration, and transmission to GPS as applicable in a timely manner;
• Seek comprehensive initial and follow-up information on Individual Case Safety Reports (ICSRs) from all relevant spontaneous sources, and (where applicable) on cases from local interventional and non-interventional studies, Patient Data Collection Systems (PDCS) and quality complaints that are combined with adverse event information in a timely manner;
• Oversee follow up activities performed in Patient Safety US including assurance that follow up information collected is medically relevant;
• Perform screening of relevant local health authority web sites according to global standards as defined by relevant quality documents;
• Determine medical relevance of new information received for follow up reports in order to determine reportability to FDA;
• Monitor appropriate Safety Database workflows to ensure timely submission of expedited ICSRs to FDA;
• Timely submit expedited cases to concerned local / central EC/IRBs as applicable;
• Ensure company sponsored clinical trials comply with global standards and FDA requirements; and
• Log onto Patient Safety US Phone line to receive incoming calls of potential adverse event reports and document information according to approved standards.

 

Requirements & Qualifications:

 

Employer requires a Bachelor's degree in a health care-related discipline and at least one (1) year of work experience in any occupation related to regulatory affairs. In addition, the employer requires the following:

 

1. Demonstrated knowledge of Good Clinical Practice (GCP), Good Pharmacovigilance (GVP) and International Conference of Harmonization (ICH) guidelines, as well as Standard Operating Procedures, gained through one (1) year of work experience.
2. Demonstrated up-to-date knowledge of Individual Case Safety Reports (ICSRs), gained through one (1) year of work experience.
3. Demonstrated ability to perform follow-up activities in US Patient Safety information collection to ensure timely submission of expedited ICSRs to the FDA, gained through one (1) year of work experience.
4. Demonstrated ability receiving incoming calls of potential adverse event reports and documenting all information, gained through one (1) year of work experience.
5. Demonstrated ability determining medical relevance of new information to determine reportability to the FDA, gained through one (1) year of work experience.

 

All years of experience may be gained concurrently.

 

Telecommuting is available, but the individual must reside within commuting distance of the Rockland, MA region, as at least one day of in-office work is required each week.

 

This position is eligible for the EMD SRDI Employee Referral Program.

 

Applicants can send resumes to EMD SRDI, 400 Summit Drive, Burlington, Massachusetts 01803 (Attn: Req#272051) or apply online https://www.emdgroup.com/en/company.html

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, str