Scientist/Senior Scientist, Aggregate Reporting

Overview

Author and coordinate aggregate safety reports and support signal management and literature reviews, in compliance with GCP and applicable global and local regulatory requirements.

What you'll do

• Author aggregate safety reports, including PBRER/PSUR, ACO, DSUR, PADER, CAR, RMP and ad-hoc safety reports for medicinal and non-medicinal products.
• Author EU-MDR PSUR, PMSR, PMSP and PRER reports for medical devices, and cosmetovigilance reports for cosmetic products, as required for health authority submissions.
• Plan report-specific timelines, identify stakeholders, request contributions and coordinate with stakeholders to obtain data for aggregate safety reports.
• Review safety data, including seriousness and expectedness assessments as necessary, per the agreed strategy and sponsor conventions, and verify the correctness and completeness of stakeholder contributions.
• Perform aggregate review of post-marketing cases in global databases and assess whether cases alter the safety profile of the marketed product.
• Conduct planning and strategic meetings and obtain inputs required for drafting and finalizing aggregate summary reports.
• Ensure aggregate summary reports are uploaded and archived in globally accepted repositories within the client environment.
• Ensure timely end-to-end report lifecycle, from drafting through approval and release to the requester.
• Draft reports in specified templates based on data evaluations and sponsor recommendations; address internal review comments and submit high-quality reports to the sponsor.
• Support literature reviews and signal management, including maintaining signal detection schedules, retrieving safety data, documenting and validating signals, and authoring signal evaluations or ad-hoc safety reports as needed.
• Maintain awareness of aggregate reporting guidelines including GVP Modules V, VI, VII and IX; ICH E2C R2; ICH E2F; EU MDR; 21 CFR 314.80/600.80; and Health Canada GVP GUI-0102.
• Perform quality reviews of reports prepared by peer aggregate report writers for correctness, completeness and sponsor compliance.
• Periodically screen designated health authority websites for safety updates, labelling recommendations, signal evaluations, pass expectations and risk minimization measures.
• Organize work to meet deadlines, comply with timelines, quality and training specified in the project SLA, and complete assigned goals and other tasks assigned by the reporting manager.
• Mentor team members, provide functional training and domain knowledge, and support capability development of junior members.
• Work independently with minimal guidance and supervision, delivering correct and complete deliverables with minimal or no rework.
• Foresee deliverable risks, alert the project lead or manager, and escalate issues impacting the delivery schedule to the team lead.
• Ensure training and timesheet compliance; comply with the QMS, ISMS and PIMS policies and the company code of conduct; report actual or potential security breaches to the regional or global DPO and security incidents to the CISO or applicable distribution list.
• Contribute to achievement of quality objectives.

What you'll need

• Bachelor's or Master's degree in life sciences or healthcare discipline, or equivalent.
• 3-6 years of experience relevant to domain or business requirements, and/or appropriate expertise or knowledge evaluated via specific assessments.
• Good knowledge of global regulatory requirements and drug safety, with a thorough understanding of regulatory guidelines.
• Familiarity with drug safety, including case management and safety databases such as ARGUS and ARIS G.
• Strong verbal and written communication skills and ability to communicate in a global environment.

Details

• Location: Bengaluru, Karnataka, India.