Description
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.
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 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 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, 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, completeness as per 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.
- Mentor and support team in their daily activities, communicate process updates to the team and ensure the implementation and compliance with the process steps defined by the Sponsor.
- Provide functional guidance to junior team members, support onboarding and conduct refresher training sessions to enhance team capability.
- Regularly track progress of assigned deliverables and communicate updates to relevant stakeholders, including participation in project or governance discussions as required (without line management accountability).
Secondary Responsibilities:
- Effectively organize assigned work and independently manage multiple deliverables to meet timelines.
- Ensure compliance to timelines, quality and training requirements as specified in the SLA.
- Mentor team members and new joiners, conduct refresher training sessions and provide constructive feedback on deliverables.
- Demonstrate quality of work and commitment through excellence in execution, ensuring correctness and completeness in deliverables with minimal or no rework.
- Alert and escalate delivery risks or issues impacting timelines to appropriate stakeholders in a timely manner.
- Ensure that all assigned goals (e.g., utilization and efficiency) are met as per set standards for the performance year.
- Independently handle assigned tasks with minimal guidance and provide technical guidance to junior team members as required.
- 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 that all project outputs and documents are always audit-ready.
- Functionally review peer deliverables for accuracy and compliance where applicable and when assigned/delegated by the line manager.
- Provide expert guidance and support the team by responding to their queries.
- Responsible for confidentiality, integrity, availability and safeguarding of data.
- Follow and comply with the Company’s Code of Conduct, Policies, and procedures.
- Responsible for reporting security incidents and PIMS breaches as applicable.
Candidate’s Profile:
- Bachelor’s or Master’s degree in life sciences or healthcare discipline, or its equivalent, in alignment with project/role/business requirements.
- 5-8 years of experience relevant to the domain/ business requirements, and/or appropriate expertise/knowledge evaluated via specific assessments.
- Advanced 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.
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