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Regional Safety Expert
- 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. We believe that it drives excellence, innovation, and human progress. We care about our customers, patients, and our rich mix of people. This diversity strengthens our ability to lead in science and technology.
We are committed to creating access and opportunities for all and empower you to fulfil your ambitions. Our diverse businesses offer various career moves to seek new horizons.
Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to bring their curiosity to life!
Curious? Chat with one of our curious minds on our interactive Q&A platform and catch a glimpse of our people, values, and culture. You can also apply and find more information at https://jobs.vibrantm.com
If you would like to know more about what diversity, equity, and inclusion means to us, please visit https://www.merckgroup.com/en/company/press-positions.html
Careers during Covid-19
Thank you for visiting our careers website, we are always looking for curious minds to join our teams. We understand how much the world is being impacted by the Covid-19 crisis and we want to assure you that your safety is very important to us. To ensure that everyone’s health is protected, instead of a standard face-to-face interview, it is likely that you will be offered alternative digital interview options. As an employee of the Company, you will be required to comply with all of the Company’s COVID-19 safety protocols and policies. The organization has currently suspended enforcement of its COVID-19 Vaccination Policy, but that policy may be reinstated by the Company in its discretion.
North America Disclosure
The Company is committed to accessibility in its workplaces, including during the job application process. Applicants who may require accommodation during the application process should speak with our Candidate Services team at 844-655-6466 from 8:00am to 5:30pm ET Monday through Friday. If you are a resident of a Connecticut or Colorado, you are eligible to receive additional information about the compensation and benefits, which we will provide upon request. You may contact 855 444 5678 from 8:00am to 5:30pm ET Monday through Friday, for assistance.
Notice on Fraudulent Job Offers
Unfortunately, we are aware of third parties that pretend to represent our company offering unauthorized employment opportunities. If you think a fraudulent source is offering you a job, please have a look at the following information: https://www.emdgroup.com/en/careers/faqs.html