Senior Scientist/Team Lead - Aggregate Reporting

Job Title: Lead - Aggregate Reporting Employment Type: Full-time Work Type: Remote

About ClinChoice: ClinChoice is a partner to the largest pharmaceutical, medical device, and consumer care innovators in the world. Established in 1995, we provide expertise in clinical operations, biometrics, regulatory affairs, pharmacovigilance, medical affairs, and toxicology to help our partners advance healthcare by accelerating clinical trials with data-driven insights, delivering the best strategies for product registration, and enhancing patient safety through real-world and clinical analysis. Our global delivery network has expanded to centers and satellite offices in the United States, Mexico, the United Kingdom, Armenia, China, Japan, India, and the Philippines to help our customers maintain regulatory compliance locally and globally. We have forged future-defining partnerships with industry bodies and technology companies to develop cutting-edge solutions that deliver our expertise with quality and precision.

• Responsible for authoring Aggregate Safety Reports (including but not limited to PBRER/PSUR, ACO, DSUR, PADER, CAR, RMP, Ad-hoc safety reports for medicinal and non-medicinal products and EU-MDR PSUR, PMSR, PMSP, and PRER reports for medical devices, and Cosmetovigilance reports for Cosmetic products for submissions to various health authorities as per the requirement).

• Plan report-specific timelines, identify relevant stakeholders, request calls for contributions, and coordinate with various stakeholders for obtaining relevant data for the preparation of aggregate safety reports.

• Review the safety data (including the seriousness and expectedness assessments of events, as may be necessary) as per the agreed strategy and sponsor’s conventions and verify the correctness and completeness of contributions received from stakeholders.

• Perform aggregate review of post-marketing cases received in global databases and assess whether the cases alter the safety profile of the marketed product.

• Coordinate with various stakeholders, conduct planning and strategic meetings and obtain inputs required for drafting and finalizing the aggregate summary reports.

• Ensure that all aggregate summary reports are uploaded and archived in the globally accepted repositories within the client environment.

• Ensure that the end-to-end life cycle of the report, from drafting up to approval and release to the requester, is conducted in a timely manner.

• Draft the reports in specified templates based on