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Regional Safety Expert
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 unimageable with us.
- Support product safety surveillance for our company medicinal products marketed globally
- Perform Collection, registration, and transmission of individual case safety reports into the Global Patient Safety Database System, ensuring compliance with underlying company internal standard processes and timelines in collaboration with and as an extension of the local patient safety team
- Review and enter the initial comprehensive information for all incoming cases and diligently perform follow-up on incomplete cases
- Screen relevant scientific literature and websites of health authorities to identify and retrieve safety information about the Company's medicinal products
- Working in close collaboration with local functions such as medical information, quality assurance, and complaint management to ensure safety reporting procedures are in place
- Ensure compliance with underlying standard processes and country specific regulations
• University degree in Pharmacy, Life science, or a similar discipline (e.g., B-Pharm, M-Pharm, Pharm.D, PhD)
• 7-10 years pharmaceutical industry experience in safety, regulatory, or clinical areas; advanced degree(s)/academic research skills
• Proven ability to handle ICSR activities mainly focusing on Intake, Triage, ICSR Follow-up and End to End ICSR management.
• Added Advantage - Prior SME experience in End to End ICSR Case processing in ArisG safety database environment, Knowledge on Therapeutic Areas & Product profile, training new staff, writing job aids and supports the line management activities in various projects.
JOB-SPECIFIC COMPETENCIES & SKILLS:
Specifies personal skills and competencies required
• Support the line manager/key user in accomplishing the assigned project tasks
• Thoroughly analyze and review all the ICSRs to determine the validity of cases received from the assigned regions to LS-IT.
• Perform minimal data entry to the mandatory fields to avoid CDVs with the accurate data that is provided from the regions.
• Perform efficient duplicate searches for all the items received at LS-IT.
• To rightly classify the ICSRs based on the duplicate search results either as Initial or Follow-up cases and dispose the item to safety system.
• Identify any missing information or incorrect data and notify the relevant LPSS to provide correct and accurate data in a timely manner.
• Identify any ICSRs that require translation and follow-up with regional colleagues to dispose the case to safety system in a timely manner without impacting the ICSR intake compliance.
• Run the COGNOS reports to identify the ICSRs that require follow-up and perform the activities as outlined in the SOP-16 and closure of cases.
• Fosters innovation and improvement related to ICSR Intake and Follow-up processes and documents, with support from manager.
• Produce high quality of work with the assigned activities.
• Identify key areas of process improvements and training needs for the team.
• Communicate with vendor/regions LPSS to guide and support them on the processes.
• Support the line manager in the project management activities.
• Clarify and agree on suitable mitigation actions in case of any process gaps identified during regular activities.
•Ensure compliance with underlying standard processes and country specific regulations
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!