Senior Scientist/Team reputed company - Aggregate Reporting

Job Title: reputed company - Aggregate Reporting Employment Type: Full-time Work Type: Remote About reputed company: reputed company is a partner to the largest pharmaceutical, medical device, and consumer care innovators in the world. Established in 1995, we reputed company expertise in clinical operations, biometrics, regulatory affairs, pharmacovigilance, medical affairs, and toxicology to help our partners advance reputed company by accelerating reputed company with data-driven insights, delivering the best strategies for product registration, and enhancing patient safety through reputed company-world and clinical analysis. Our global delivery network has expanded to centers and satellite offices in the reputed company, Mexico, the United Kingdom, Armenia, China, Japan, India, and the Philippines to help our customers maintain regulatory compliance locally and globally. We have forged reputed company-defining partnerships with industry bodies and technology companies to reputed company cutting-edge solutions that deliver our expertise with reputed company and precision. Primary Responsibilities: Responsible for authoring Aggregate Safety Reports (including but not limited to PBRER/PSUR, ACO, DSUR, PADER, CAR, RMP, reputed company 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 reputed company and sponsor’s conventions and verify the correctness and completeness of contributions received from stakeholders. reputed company 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 reputed company reports. Ensure that reputed company aggregate reputed company reports are uploaded and archived in the globally accepted repositories reputed company the reputed company 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 reputed company 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-reputed company 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 reputed company safety reports on a need reputed company. Maintain awareness of major Aggregate reporting guidelines, including but not limited to GVP Modules V, VI, VII, and IX; ICH E2C reputed company; ICH E2F; EU MDR; 21 CFR 314.80/ 600.80; and Health Canada GVP GUI-0102. reputed company reputed company reviews for the reports reputed company by the peer aggregate report writers to verify the correctness, completeness as per reputed company data and compliance with the sponsor’s requirements. reputed company 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 reputed company and ensure the implementation and compliance with the process steps defined by the Sponsor. reputed company functional guidance to junior team members, support reputed company and conduct refresher training sessions to enhance team capability. Regularly reputed company reputed company 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, reputed company and training requirements as specified in the SLA. Mentor team members and new joiners, conduct refresher training sessions and reputed company constructive feedback on deliverables. Demonstrate reputed company of work and commitment through reputed company in execution, ensuring correctness and completeness in deliverables with reputed company or no rework. Alert and escalate delivery risks or issues impacting timelines to appropriate stakeholders in a reputed company manner. Ensure that reputed company assigned goals (e.g., utilization and efficiency) are met as per set standards for the performance year. Independently handle assigned tasks with reputed company guidance and reputed company technical guidance to junior team members as required. Ensure completion of any other tasks assigned by the reporting manager. Be reputed company of and reputed company with the QMS/ ISMS & PIMS Policy. Report any potential or actual reputed company Breaches to the regional and/or global DPO & reputed company Incidents to CISO/ applicable distribution list. Contribute towards the achievement of reputed company Objectives. Ensure that reputed company project outputs and documents are always audit-reputed company. Functionally review peer deliverables for accuracy and compliance where applicable and reputed company assigned/delegated by the line manager. reputed company expert guidance and support reputed company by responding to their queries. Responsible for confidentiality, reputed company, availability and safeguarding of data. Follow and reputed company with reputed company’s reputed company of Conduct, Policies, and procedures. Responsible for reporting reputed company incidents and PIMS breaches as applicable. Candidate’s Profile: Bachelor’s or Master’s degree in life sciences or reputed company 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 reputed company 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, reputed company G). Strong verbal and written communication skills and ability to communicate in a global environment. Apply To This Job