{"id":4179547,"url":"https://alion.io/job/clinchoice-scientistsenior-scientist-aggregate-reporting","title":"Scientist/Senior Scientist, Aggregate Reporting","company":{"id":672996,"name":"ClinChoice","domain":"clinchoice.com","url":"https://alion.io/company/clinchoice","size_band":"1001-5000","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Greenhouse","truth_index":{"grade":"B","score":78,"open_postings":17,"ghost_share":0,"stale_share":0.882,"repost_share":0,"time_to_fill_p50_days":34,"computed_at":"2026-11-12T10:38:37Z"}},"role":"Science & Research","role_family":"Science & Research","seniority":"senior","employment_type":null,"work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Bengaluru, India"],"countries":["IN"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":null,"experience_years_min":null,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"DPO","optional":false},{"name":"EU MDR","optional":false},{"name":"GCP","optional":false},{"name":"Good Clinical Practice","optional":false}],"status":"live","first_seen_at":"2026-11-12T12:04:21Z","employer_posted_date":"2026-11-12","last_verified_at":"2026-11-12T17:07:51Z","board_verified":true,"closed_at":null,"days_open":0,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":0},"description":"Purpose:\nThe 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.\nPrimary Responsibilities: \nResponsible 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).\nPlan 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.\nReview 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.\nPerform an aggregate review of post-marketing cases received in global databases and assess whether the cases alter the safety profile of the marketed product.\nCoordinate with various stakeholders, conduct planning and strategic meetings and obtain inputs required for drafting and finalizing the aggregate summary reports.\nEnsure that all aggregate summary reports are uploaded and archived in the globally accepted repositories within the client environment.\nEnsure 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.\nDraft the reports in specified templates based on the data evaluations and the sponsor’s recommendations.\nAddress the review comments from internal stakeholders and submit the high-quality report to the Sponsor.\nSupport 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.\nMaintain 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.\nPerform 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.\nPerform periodic screening of designated HA websites for safety updates, labelling recommendations, signal evaluations, pass expectations and risk minimization measures. \nSecondary Responsibilities:\nEffectively organize work to complete the assigned tasks to meet deadlines.\nEnsure compliance with timelines, quality and training as specified in the project SLA.\nMentor and bestow domain knowledge to the team.\nDemonstrate Quality of Work & Commitment through excellence in work, ensure correctness and completeness in deliverables with minimum OR no re-work.\nAble 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.\nResponsible for ensuring training compliance and timesheet compliance. \nEnsure completion of any other tasks assigned by the reporting manager.\nBe aware of and comply with the QMS/ ISMS & PIMS Policy.\nReport any potential or actual Security Breaches to the regional and/or global DPO & Security Incidents to CISO/ applicable distribution list.\nContribute towards the achievement of Quality Objectives.\nEnsure 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.\nConduct functional training for the team members and support the capability development of junior members.\nAlert and escalate to TL as required, whenever project deliverable risks are visualized or issues encountered impacting the delivery schedule.\nFollow and comply with the Company’s code of conduct, policies, and procedures. \nSkills and Qualifications:\nBachelor’s or Master’s degree in life sciences or healthcare discipline, or its equivalent, in alignment with project/role/business requirements.\n3-6 years - experience relevant for domain/ business requirements, and/OR appropriate expertise/knowledge evaluated via specific assessments.\nGood knowledge of global regulatory requirements and drug safety, and a thorough understanding of Regulatory guidelines.\nFamiliar with drug safety (case management, familiarity with safety databases like ARGUS, ARIS G).\nStrong verbal and written communication skills and ability to communicate in a global environment.","description_format":"text","description_chars":5196,"description_truncated":false,"requirements":{"experience_years_min":null,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[]},"benefits":[],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Clinical Trial Services (CRO)"],"lifecycle":[{"event":"open","at":"2026-11-12T17:07:51Z"}],"visa":[],"liveness":{"score":86,"band":"hot","label":"Hiring now","p_open":1,"p_active":0.86,"p_room":1,"age_days":0,"expected_fill_days":34,"reasons":["conf:6","win:early"],"computed_at":"2026-11-13T00:02:49Z"},"pay":null,"html_url":"https://alion.io/job/clinchoice-scientistsenior-scientist-aggregate-reporting","json_url":"https://alion.io/job/clinchoice-scientistsenior-scientist-aggregate-reporting.json","meta":{"generated_at":"2026-11-13T00:02:49Z","cache_seconds":300,"methodology":"https://alion.io/methodology","terms":"https://alion.io/terms","contact":"https://alion.io/contact","api":"https://alion.io/developers","about":"Alion is a live layer of people, companies and AI agents: who they are, whether they are real and active right now, what they do and how to work with them, readable by people and by agents and paid per call.","catalog":"https://alion.io/catalog.json","usage":{"tier":"crawler_verified","counted_by":"address","units_charged":1,"used_today":102,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-11-14T00:00:00Z"}},"offers":[{"id":"company.slices","title":"One company in depth, by slice","status":"live","price":{"credits":0.1,"usd":0.01,"plus_per_slice":{"credits":0.05,"usd":0.005}},"unit":"per company, plus each slice with data","note":"the employer in depth","call":{"mcp_tool":"get_company","arguments":{"id":672996},"rest":"https://alion.io/mcp/rest/get_company?id=672996"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fclinchoice-scientistsenior-scientist-aggregate-reporting"},{"id":"market.stats","title":"A market slice: pay, demand and time to fill","status":"free","price":{"credits":0,"usd":0},"unit":"per slice","note":"pay, demand and time to fill for this role and place","call":{"mcp_tool":"market_stats"},"human":"https://alion.io/catalog?offer=market.stats&for=job%2Fclinchoice-scientistsenior-scientist-aggregate-reporting"},{"id":"job.search","title":"Open jobs by role, technology, place, pay and visa","status":"live","price":{"credits":0.1,"usd":0.01},"unit":"per posting in a list","note":"similar open postings","call":{"mcp_tool":"search_jobs"},"human":"https://alion.io/catalog?offer=job.search&for=job%2Fclinchoice-scientistsenior-scientist-aggregate-reporting"},{"id":"company.verify","title":"Is this company real and active right now","status":"pilot","price":null,"unit":"per company","request":{"url":"https://alion.io/catalog/request","method":"POST","body":"{\"offer\": \"company.verify\", \"for\": \"job/clinchoice-scientistsenior-scientist-aggregate-reporting\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fclinchoice-scientistsenior-scientist-aggregate-reporting"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":4179547}},{"tool":"search_jobs","arguments":{"company":"clinchoice.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":4179547},"note":"people open to offers who fit this vacancy"}],"note":"The same data through MCP tools: https://alion.io/mcp/open needs no sign-in (compact searches, postings, people); https://alion.io/mcp with an Alion account has everything. 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