Purpose:
The purpose of this job description is to define the minimum qualifications and experience required, as well as the responsibilities of the Scientist – Aggregate Reporting. The aim is to ensure that job duties are performed in compliance with the company’s training program and all applicable global and local regulatory requirements, including but not limited to Good Clinical Practices (GCP), ISO standards, data protection laws, and other relevant local regulations.
Primary Responsibilities:
- 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 an 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 the data evaluations and the sponsor’s recommendations.
- Address the review comments from internal stakeholders and submit the high-quality report to the Sponsor.
- Support in literature reviews and signal management activities, including but not limited to maintaining signal detection schedules, retrieval of safety data and reviews, documentation of signal assessments/detections, signal validation, and evaluations, and authoring of signal evaluations or ad-hoc safety reports on a need basis.
- Maintain awareness of major Aggregate reporting guidelines, including but not limited to 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 for the reports prepared by the peer aggregate report writers to verify the correctness and completeness as per the source data and compliance with the sponsor’s requirements.
- Perform periodic screening of designated HA websites for safety updates, labelling recommendations, signal evaluations, pass expectations and risk minimization measures.
Secondary Responsibilities:
- Effectively organize work to complete the assigned tasks to meet deadlines.
- Ensure compliance with timelines, quality and training as specified in the project SLA.
- Mentor and bestow domain knowledge to the team.
- Demonstrate Quality of Work & Commitment through excellence in work, ensure correctness and completeness in deliverables with minimum OR no re-work.
- Able to independently perform tasks with minimal guidance & supervision. Ensure that all assigned goals [e.g., utilization and efficiency] are met as per set standards for the performance year.
- Responsible for ensuring training compliance and timesheet compliance.
- Ensure completion of any other tasks assigned by the reporting manager.
- Be aware of and comply with the QMS/ ISMS & PIMS Policy.
- Report any potential or actual Security Breaches to the regional and/or global DPO & Security Incidents to CISO/ applicable distribution list.
- Contribute towards the achievement of Quality Objectives.
- Ensure proper planning of the deliverable, foresee any risks that are likely to arise and alert the project lead/ manager whenever project deliverable risks are visualized.
- Conduct functional training for the team members and support the capability development of junior members.
- Alert and escalate to TL as required, whenever project deliverable risks are visualized or issues encountered impacting the delivery schedule.
- Follow and comply with the Company’s code of conduct, policies, and procedures.
Skills and Qualifications:
- Bachelor’s or Master’s degree in life sciences or healthcare discipline, or its equivalent, in alignment with project/role/business requirements.
- 3-6 years - experience relevant for domain/ business requirements, and/OR appropriate expertise/knowledge evaluated via specific assessments.
- Good knowledge of global regulatory requirements and drug safety, and a thorough understanding of Regulatory guidelines.
- Familiar with drug safety (case management, familiarity with safety databases like ARGUS, ARIS G).
- Strong verbal and written communication skills and ability to communicate in a global environment.
