{"id":2803540,"url":"https://alion.io/job/synapmed-safety-system-manager-it-infrastructure","title":"Safety System Manager - IT Infrastructure","company":{"id":4445226,"name":"Synapmed","domain":"synapmed.com","url":"https://alion.io/company/synapmed","size_band":null,"is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":null,"truth_index":null},"role":"DevOps","role_family":"DevOps","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":["Hyderabad, India","Noida, India"],"countries":["IN"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":17500,"max_usd":38000,"period":"year","method":"role_seniority_country_remote_cell","sample_n":43},"experience_years_min":6,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"AI Agents","optional":false},{"name":"Azure DevOps","optional":false},{"name":"CAPA","optional":false},{"name":"E2B","optional":false},{"name":"EU AI Act","optional":false},{"name":"Human-in-the-Loop","optional":false},{"name":"ITIL","optional":false},{"name":"Jira","optional":false},{"name":"LLM","optional":false},{"name":"Oracle","optional":false},{"name":"ServiceNow","optional":false},{"name":"SQL","optional":false},{"name":"Azure","optional":true},{"name":"Confluence","optional":true},{"name":"Incident Management","optional":true},{"name":"Power Automate","optional":true},{"name":"PubMed","optional":true},{"name":"Rest API","optional":true},{"name":"SharePoint","optional":true},{"name":"SOAP","optional":true},{"name":"UiPath","optional":true}],"status":"live","first_seen_at":"2026-07-22T04:23:39Z","employer_posted_date":null,"last_verified_at":"2026-07-22T04:23:39Z","board_verified":false,"closed_at":null,"days_open":89,"trust":{"level":"not_scored","repost_count":null,"flags":[],"days_open":89},"description":"Job description\nJOB DESCRIPTION\nSenior Safety Database SME Team Lead\nPharmacovigilance Technology & Managed Services | Client-Facing Role\n1. ROLE OVERVIEW\nJob Title\nManager Safety Systems\nDepartment\nTechnology Safety Systems Practice\nReports To\nHead of Technology\nExperience Required\n610 Years\nWork Model\nPreferred Job Location: Hyderabad/Noida; remote on approval basis. Occasional client-site travel\nEngagement Model\nClient-facing across multiple global pharma and biotech clients\nIndustry Context\nPharmacovigilance (PV), CRO Services, Safety Platform Implementation & Managed Services\n2. KEY RESPONSIBILITIES\nManaged Services, Incident & Ticket Management\nServe as the senior escalation point for safety system incidents, defects, and service requests across client accounts.\nOwn ticket triage, root-cause analysis (RCA), workaround design, and permanent-fix coordination within defined SLAs; drive continuous-improvement plans on recurring issues.\nConduct weekly and monthly service reviews with client IT, PV Operations, and QA stakeholders; present KPIs on ticket volumes, MTTR, CAPAs, and system health.\nDefine and evolve runbooks, knowledge-based articles, and standard operating procedures for L1/L2 teams to drive self-sufficiency.\nEnsure adherence to ITIL-aligned incident, problem, change, and release management processes across all supported client estates.\nTechnical & Business Configuration (including Product, Study & Unblinding)\nDesign, implement, and maintain technical configurations workflows, case processing rules, expedited and periodic reporting rules, user groups and roles, site and org hierarchies, interfaces, and scheduled jobs.\nLead business configuration codelists, flexible re-categorization, MedDRA and WHO-Drug dictionary uploads and versioning, letters and templates, advanced conditions, and console-level settings.\nOwn product configuration parent/child licensing, investigational vs. marketed status, combination products, biosimilars, and license-country mappings aligned to each client's regulatory footprint.\nOwn study configuration for interventional trials, observational studies, and registries including single-blind, double-blind, and open-label studies.\nDesign, execute, and document controlled unblinding workflows in safety systems in compliance with protocol, SOPs, and regulatory expectations (FDA IND safety reporting, EMA CT Regulation 536/2014, ICH E6(R3)).\nEnsure role-based access controls, segregation of duties, and full audit traceability for blinded treatment information and emergency unblinding events.\nPartner with PV Operations leads to translate business requirements into configuration specifications, impact assessments, and test scripts.\nData Migrations & Platform Transitions\nLead end-to-end safety data migrations legacy-to-modern (e.g., Argus to LifeSphere Safety or Vault Safety), version upgrades, consolidation of multiple legacy instances, and CRO-to-sponsor transitions.\nDefine migration strategy, data mapping, cleansing rules, reconciliation approach, cutover plan, and fallback procedures.\nDrive extraction, transformation, load, and verification cycles (mock migrations, UAT, production cutover); author migration protocols and final reports.\nPartner with QA on Computer System Validation (CSV) / Computer Software Assurance (CSA) deliverables per GAMP 5 (2nd Edition), 21 CFR Part 11, and EU Annex 11.\nIntegrations & Interoperability\nConfigure and troubleshoot E2B(R2) and E2B(R3) ICSR gateways for FDA FAERS, EMA EudraVigilance (EVWEB / EVPOST), PMDA, Health Canada, MHRA, and other national authorities.\nManage MedDRA (SMQs, LLT/PT hierarchy) and WHO-Drug dictionary upgrades, re-coding, and impact analysis.\nSupport integrations with clinical trial systems (EDC, CTMS), signal management platforms, literature monitoring tools, and document management systems.\nAudit Readiness, CSV/CSA, Change Control & CAPA\nServe as the senior IT/technology point of contact during internal audits, client audits, and regulatory inspections (FDA, EMA, MHRA, PMDA); support inspection readiness walkthroughs, data integrity reviews, and audit trail demonstrations.\nLead Computer System Validation (CSV) and Computer Software Assurance (CSA) activities for safety platforms authoring and reviewing URS, FRS, CS, IQ/OQ/PQ protocols, Requirements Traceability Matrix (RTM), validation summary reports, and periodic re-validation plans.\nApply risk-based validation and CSA principles aligned to GAMP 5 (2nd Edition), ISPE GAMP RDI/Data Integrity guidance, 21 CFR Part 11, and EU Annex 11; rationalise testing depth based on system impact, novelty, and criticality.\nOwn end-to-end change control for configuration, platform upgrades, patches, and integration changes impact assessments, validation scoping, pre- and post-implementation testing, rollback planning, and release approval in eQMS.\nMaintain validated state through controlled change, periodic review, and audit trail review; ensure segregation of duties and proper documentation for every configuration release.\nDrive the CAPA process for system-level deviations, ticket trends, audit findings, and non-conformances root-cause analysis, corrective and preventive action design, effectiveness checks, and closure within QMS timelines.\nEnsure ALCOA+ data integrity principles (Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, Available) are enforced in configurations, interfaces, and migration activities.\nPartner with QA, Regulatory, and client Quality leads to maintain validation documentation in an inspection-ready state at all times; respond to audit observations with documented evidence and remediation plans.\nCase Processing Lifecycle & Regulatory Submissions\nProvide platform-level guidance across the full ICSR lifecycle intake, book-in, data entry, MedDRA coding, medical review, QC, reporting, and archival.\nConfigure and troubleshoot all case submission scenarios Initial, Follow-up, Downgrade, Nullification/Amendment, and re-submission workflows across clinical trial and post-marketing contexts.\nSupport and validate report generation across ICSR and aggregate report types including E2B(R2), E2B(R3), CIOMS, MedWatch, PADER, PBRER, PSUR, DSUR, and local-authority-specific formats (e.g., J-specific for PMDA).\nAdvise client teams on fluency with ICH E2A, E2B(R3), E2C(R2), E2D, and E2E as these translate into system behaviour and configuration choices.\nAI, Automation & Intelligent Pharmacovigilance\nStay current on regulatory guidance on AI in PV, including the FDA Draft Guidance on AI to Support Regulatory Decision-Making (Jan 2025), the joint FDAEMA Guiding Principles of Good AI Practice in Drug Development (Jan 2026), EMA's AI Reflection Paper, and the HMAEMA Multiannual AI Workplan.\nAdvise clients on fit-for-purpose AI/ML and GenAI use cases across the case lifecycle intelligent intake, auto-narrative generation, MedDRA auto-coding, duplicate detection, seriousness/causality triage support, listedness assessment, and signal detection.\nEvaluate vendor AI modules (e.g., built-in LLM and agentic features within safety platforms) for validation readiness, bias, explainability, human-in-the-loop design, and GxP compliance.\nContribute to internal accelerators, prompt libraries, and automation frameworks that improve ticket resolution, configuration QC, and migration reconciliation.\nClient Advisory & Stakeholder Management\nAct as trusted technical advisor to client PV, IT, QA, and Regulatory stakeholders; translate complex technical concepts into business outcomes.\nLead solution design workshops, fit-gap assessments, and platform evaluation exercises.\nRepresent the practice in client meetings and audit/inspection support.\nTeam Leadership & Practice Development\nLead, mentor, and develop a team, configuration analysts, and support engineers across geographies.\nProvide technical direction on configurations, migrations, incident resolution, and validation deliverables, review work for quality and compliance.\nMentor team members, unblock technical issues, and guide problem-solving on complex client scenarios.\nSupport onboarding, knowledge sharing, and upskilling on safety platforms, SQL/PL/SQL, and AI trends in PV.\n3. REQUIRED SKILLS & EXPERIENCE\nPharmacovigilance Fundamentals & Case Lifecycle (Must-Have)\nStrong grounding in pharmacovigilance regulatory definitions (AE/SAE/SUSAR), expectedness, causality, seriousness, and listedness assessments.\nEnd-to-end understanding of the ICSR case processing lifecycle: intake, book-in, data entry, MedDRA coding, medical review, QC, reporting, and archival.\nHands-on knowledge of all case submission scenarios Initial, Follow-up, Downgrade, Nullification/Amendment, and re-submission workflows across clinical trial and post-marketing contexts.\nWorking knowledge of all major ICSR and aggregate report types, including but not limited to: E2B(R2), E2B(R3), CIOMS, MedWatch, PADER, PBRER, PSUR, DSUR, and local-authority-specific formats (e.g., J-specific for PMDA).\nFluency with ICH E2A, E2B(R3), E2C(R2), E2D, E2E, and MedDRA/WHO-Drug usage in a regulated environment.\nCore Safety Systems Expertise (Must-Have)\n610 years of progressive experience supporting safety systems in a CRO, pharma, biotech, or technology-vendor environment.\nDeep, hands-on expertise with at least two of: Oracle Argus Safety (7.x/8.x), ArisGlobal LifeSphere Safety / agXchange, Veeva Vault Safety. Willingness and ability to work platform-agnostic across client estates.\nDemonstrated experience across the full lifecycle: implementation, go-live, hypercare, steady-state managed services, upgrades, and decommissioning.\nProven track record leading at least one large safety data migration or platform transition end-to-end.\nExperience leading and mentoring distributed teams of 5+ technical and functional specialists.\nRegulatory Knowledge (Must-Have)\nStrong working knowledge of FDA regulations 21 CFR 314.80/600.80, 21 CFR Part 11, FAERS submissions, VAERS (where applicable), and IND/NDA/BLA safety reporting.\nSolid command of EMA requirements.\nHands-on familiarity with PMDA J-specific requirements (J2.4 code, J-reporting) and global ICSR exchange via ICH E2B(R2) and E2B(R3).\nCompliance, Audit & Validation (Must-Have)\nHands-on experience with Computer System Validation (CSV) and Computer Software Assurance (CSA) lifecycle for GxP-regulated safety platforms URS, FRS, IQ/OQ/PQ, RTM, and validation summary reports.\nStrong working knowledge of GAMP 5 (2nd Edition), 21 CFR Part 11, EU Annex 11, ALCOA+ data integrity principles, and risk-based testing approaches.\nDemonstrated experience owning change control processes impact assessments, validation scoping, approvals, and release governance within an eQMS environment.\nProven ability to drive the CAPA lifecycle for system-level issues RCA, corrective/preventive action definition, effectiveness checks, and closure.\nPrior experience supporting internal, client, and regulatory audits (FDA, EMA, MHRA, PMDA) as an IT/technology SME; comfortable authoring audit responses and remediation plans.\nTechnical Skills (Must-Have)\nStrong, hands-on proficiency in SQL and PL/SQL able to write complex queries, analyse execution plans, and debug procedures directly in safety systems, comfortable reading and interpreting database schemas independently.\nComfortable with XML (including E2B schemas), log analysis, and troubleshooting configuration and integration issues without hand-holding.\nFamiliarity with middleware and integration patterns (APIs, web services, gateways, ESBs) and with database administration concepts relevant to PV platforms.\nComfortable with ticketing and ALM tools (e.g., ServiceNow, Jira, HP ALM, Azure DevOps) and with documentation standards for regulated systems.\nAI & Modern Practices (Must-Have)\nDemonstrated awareness of GenAI and agentic AI developments relevant to PV large language models for narrative generation, auto-coding, triage assistance, and signal detection.\nAbility...","description_format":"text","description_chars":15471,"description_truncated":true,"requirements":{"experience_years_min":6,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":null,"security_clearance":false,"languages":[]},"benefits":[],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Biotechnology"],"lifecycle":[{"event":"open","at":"2026-10-18T01:22:52Z"}],"visa":[],"liveness":{"score":5,"band":"cold","label":"Long shot","p_open":0.4,"p_active":0.455,"p_room":0.28,"age_days":89,"expected_fill_days":26,"reasons":["seen:89","win:tail","crowd:"],"computed_at":"2026-10-19T05:45:15Z"},"pay":null,"html_url":"https://alion.io/job/synapmed-safety-system-manager-it-infrastructure","json_url":"https://alion.io/job/synapmed-safety-system-manager-it-infrastructure.json","meta":{"generated_at":"2026-10-20T03:27:56Z","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":3739,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-21T00:00:00Z"}},"offers":[{"id":"company.slices","title":"One company in depth, by slice","status":"live","price":{"credits":0.02,"usd":0.002,"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":4445226},"rest":"https://alion.io/mcp/rest/get_company?id=4445226"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fsynapmed-safety-system-manager-it-infrastructure"},{"id":"market.stats","title":"A market slice: pay, demand and time to fill","status":"live","price":{"credits":1,"usd":0.1},"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%2Fsynapmed-safety-system-manager-it-infrastructure"},{"id":"job.search","title":"Open jobs by role, technology, place, pay and visa","status":"live","price":{"credits":0.02,"usd":0.002},"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%2Fsynapmed-safety-system-manager-it-infrastructure"},{"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/synapmed-safety-system-manager-it-infrastructure\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fsynapmed-safety-system-manager-it-infrastructure"}]}