JOB DESCRIPTION

Senior Safety Database SME Team Lead

Pharmacovigilance Technology & Managed Services | Client-Facing Role

1. ROLE OVERVIEW

Job Title

Manager – Safety Systems

Department

Technology – Safety Systems Practice

Reports To

Head of Technology

Experience Required

6–10 Years

Work Model

Preferred Job Location: Hyderabad/Noida; remote on approval basis. Occasional client-site travel

Engagement Model

Client-facing across multiple global pharma and biotech clients

Industry Context

Pharmacovigilance (PV), CRO Services, Safety Platform Implementation & Managed Services

2. KEY RESPONSIBILITIES

Managed Services, Incident & Ticket Management

- Serve as the senior escalation point for safety system incidents, defects, and service requests across client accounts.
- Own ticket triage, root-cause analysis (RCA), workaround design, and permanent-fix coordination within defined SLAs; drive continuous-improvement plans on recurring issues.
- Conduct weekly and monthly service reviews with client IT, PV Operations, and QA stakeholders; present KPIs on ticket volumes, MTTR, CAPAs, and system health.
- Define and evolve runbooks, knowledge-based articles, and standard operating procedures for L1/L2 teams to drive self-sufficiency.
- Ensure adherence to ITIL-aligned incident, problem, change, and release management processes across all supported client estates.

Technical & Business Configuration (including Product, Study & Unblinding)

- Design, 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.
- Lead business configuration – codelists, flexible re-categorization, MedDRA and WHO-Drug dictionary uploads and versioning, letters and templates, advanced conditions, and console-level settings.
- Own product configuration – parent/child licensing, investigational vs. marketed status, combination products, biosimilars, and license-country mappings aligned to each client's regulatory footprint.
- Own study configuration for interventional trials, observational studies, and registries – including single-blind, double-blind, and open-label studies.
- Design, 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)).
- Ensure role-based access controls, segregation of duties, and full audit traceability for blinded treatment information and emergency unblinding events.
- Partner with PV Operations leads to translate business requirements into configuration specifications, impact assessments, and test scripts.

Data Migrations & Platform Transitions

- Lead 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.
- Define migration strategy, data mapping, cleansing rules, reconciliation approach, cutover plan, and fallback procedures.
- Drive extraction, transformation, load, and verification cycles (mock migrations, UAT, production cutover); author migration protocols and final reports.
- Partner 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.

Integrations & Interoperability

- Configure and troubleshoot E2B(R2) and E2B(R3) ICSR gateways for FDA FAERS, EMA EudraVigilance (EVWEB / EVPOST), PMDA, Health Canada, MHRA, and other national authorities.
- Manage MedDRA (SMQs, LLT/PT hierarchy) and WHO-Drug dictionary upgrades, re-coding, and impact analysis.
- Support integrations with clinical trial systems (EDC, CTMS), signal management platforms, literature monitoring tools, and document management systems.

Audit Readiness, CSV/CSA, Change Control & CAPA

- Serve 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.
- Lead 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.
- Apply 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.
- Own 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.
- Maintain validated state through controlled change, periodic review, and audit trail review; ensure segregation of duties and proper documentation for every configuration release.
- Drive 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.




- Ensure ALCOA+ data integrity principles (Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, Available) are enforced in configurations, interfaces, and migration activities.
- Partner 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.

Case Processing Lifecycle & Regulatory Submissions

- Provide platform-level guidance across the full ICSR lifecycle – intake, book-in, data entry, MedDRA coding, medical review, QC, reporting, and archival.
- Configure and troubleshoot all case submission scenarios – Initial, Follow-up, Downgrade, Nullification/Amendment, and re-submission workflows – across clinical trial and post-marketing contexts.
- Support 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).
- Advise client teams on fluency with ICH E2A, E2B(R3), E2C(R2), E2D, and E2E as these translate into system behaviour and configuration choices.

AI, Automation & Intelligent Pharmacovigilance

- Stay current on regulatory guidance on AI in PV, including the FDA Draft Guidance on AI to Support Regulatory Decision-Making (Jan 2025), the joint FDA–EMA Guiding Principles of Good AI Practice in Drug Development (Jan 2026), EMA's AI Reflection Paper, and the HMA–EMA Multiannual AI Workplan.
- Advise 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.
- Evaluate 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.
- Contribute to internal accelerators, prompt libraries, and automation frameworks that improve ticket resolution, configuration QC, and migration reconciliation.

Client Advisory & Stakeholder Management

- Act as trusted technical advisor to client PV, IT, QA, and Regulatory stakeholders; translate complex technical concepts into business outcomes.
- Lead solution design workshops, fit-gap assessments, and platform evaluation exercises.
- Represent the practice in client meetings and audit/inspection support.

Team Leadership & Practice Development

- Lead, mentor, and develop a team, configuration analysts, and support engineers across geographies.
- Provide technical direction on configurations, migrations, incident resolution, and validation deliverables, review work for quality and compliance.
- Mentor team members, unblock technical issues, and guide problem-solving on complex client scenarios.
- Support onboarding, knowledge sharing, and upskilling on safety platforms, SQL/PL/SQL, and AI trends in PV.

3. REQUIRED SKILLS & EXPERIENCE

Pharmacovigilance Fundamentals & Case Lifecycle (Must-Have)

- Strong grounding in pharmacovigilance – regulatory definitions (AE/SAE/SUSAR), expectedness, causality, seriousness, and listedness assessments.
- End-to-end understanding of the ICSR case processing lifecycle: intake, book-in, data entry, MedDRA coding, medical review, QC, reporting, and archival.
- Hands-on knowledge of all case submission scenarios – Initial, Follow-up, Downgrade, Nullification/Amendment, and re-submission workflows – across clinical trial and post-marketing contexts.
- Working 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).
- Fluency with ICH E2A, E2B(R3), E2C(R2), E2D, E2E, and MedDRA/WHO-Drug usage in a regulated environment.

Core Safety Systems Expertise (Must-Have)

- 6–10 years of progressive experience supporting safety systems in a CRO, pharma, biotech, or technology-vendor environment.
- Deep, 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.
- Demonstrated experience across the full lifecycle: implementation, go-live, hypercare, steady-state managed services, upgrades, and decommissioning.
- Proven track record leading at least one large safety data migration or platform transition end-to-end.
- Experience leading and mentoring distributed teams of 5+ technical and functional specialists.

Regulatory Knowledge (Must-Have)

- Strong 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.
- Solid command of EMA requirements.




- Hands-on familiarity with PMDA J-specific requirements (J2.4 code, J-reporting) and global ICSR exchange via ICH E2B(R2) and E2B(R3).

Compliance, Audit & Validation (Must-Have)

- Hands-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.
- Strong working knowledge of GAMP 5 (2nd Edition), 21 CFR Part 11, EU Annex 11, ALCOA+ data integrity principles, and risk-based testing approaches.
- Demonstrated experience owning change control processes – impact assessments, validation scoping, approvals, and release governance – within an eQMS environment.
- Proven ability to drive the CAPA lifecycle for system-level issues – RCA, corrective/preventive action definition, effectiveness checks, and closure.
- Prior experience supporting internal, client, and regulatory audits (FDA, EMA, MHRA, PMDA) as an IT/technology SME; comfortable authoring audit responses and remediation plans.

Technical Skills (Must-Have)

- Strong, 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.
- Comfortable with XML (including E2B schemas), log analysis, and troubleshooting configuration and integration issues without hand-holding.
- Familiarity with middleware and integration patterns (APIs, web services, gateways, ESBs) and with database administration concepts relevant to PV platforms.
- Comfortable with ticketing and ALM tools (e.g., ServiceNow, Jira, HP ALM, Azure DevOps) and with documentation standards for regulated systems.

AI & Modern Practices (Must-Have)

- Demonstrated awareness of GenAI and agentic AI developments relevant to PV – large language models for narrative generation, auto-coding, triage assistance, and signal detection.
- Ability to critically evaluate AI features in vendor roadmaps against GxP, 21 CFR Part 11, EU AI Act (high-risk system) expectations, and the FDA/EMA Guiding Principles for Good AI Practice.

Nice to Have

- Hands-on MedDRA coding experience, including selection of appropriate LLTs, use of SMQs, and auto-coding QC – ability to review and adjudicate coding decisions made by analysts or AI tools.
- Understanding of signal detection methodologies (disproportionality analysis, PRR, ROR, EBGM) and exposure to platforms such as Oracle Empirica Signal, ArisGlobal LifeSphere Signal, or Veeva Vault Signal.
- Understanding of literature monitoring processes and tools (e.g., Embase, PubMed, EMA MLM, commercial literature platforms), including search strategy design and relevance screening.
- Exposure to medical information or risk management platforms.
- Experience operating under Internal, Regulatory, Client or sponsor inspections/audits.

Leadership & Soft Skills

- Strong leadership, communication, and stakeholder management skills; confident presenting to senior client stakeholders.
- Strong consulting mindset – active listening, issue framing, structured problem-solving, and outcome orientation.
- Ability to manage multiple priorities across managed services, delivery milestones, and strategic initiatives.
- Comfortable working across global time zones and with cross-functional client teams; disciplined around documentation and handovers.

4. TOOLS & TECHNOLOGIES

Type

Category

Tools / Technologies

Mandatory

Safety Databases

Oracle Argus Safety (7.x/8.x), ArisGlobal LifeSphere Safety / agXchange, Veeva Vault Safety

Preferred

Signal Management

Oracle Empirica Signal, ArisGlobal LifeSphere Signal, Veeva Vault Signal

Preferred

Literature Monitoring

Embase, PubMed, EMA MLM, commercial literature platforms

Mandatory

Regulatory Gateways

FDA ESG, EMA EudraVigilance (EVWEB / EVPOST), PMDA, Health Canada, MHRA

Mandatory

Dictionaries & Standards

MedDRA (SMQs, LLT/PT), WHO-Drug, ICH E2B(R2)/R3 schemas, XEVMPD

Mandatory

Databases & Querying

Oracle DB, SQL, PL/SQL, XML, log analysis tools

Preferred

ITSM & ALM

ServiceNow, Jira, HP ALM, Azure DevOps (ITIL-based workflows)

Mandatory

Validation & Compliance

CSV / CSA documentation tools, eQMS platforms (Veeva Vault QMS, TrackWise, MasterControl), audit trail management, GAMP 5 (2nd Ed.), ALCOA+

Mandatory

Change Control & CAPA

eQMS change control modules, RTM tools, validation document repositories, deviation and CAPA workflows

Mandatory

Integrations

E2B gateways, REST/SOAP APIs, middleware / ESB, EDC and CTMS interfaces

Preferred

AI & Automation

GenAI and LLM-based intake/triage tools, auto-coding engines, RPA (Power Automate / UiPath), AI-assisted ITSM

Mandatory

Collaboration

Microsoft Teams, SharePoint, Confluence, enterprise communication platforms

5. SPECIAL CONDITIONS

- Willingness to work flexible schedule to support global client time zones (EU, US, APAC).
- Availability for regulatory inspections, client audits, go-live cutovers, and business continuity scenarios on short notice.
- Travel may be required for client visits, go-lives, audits, or organizational meetings.
- Comfortable operating as the senior technical voice in client and internal meetings.

The statements in this document reflect the general responsibilities and requirements of this role. They are not intended to be an exhaustive list of all duties and qualifications.

📌 Safety Systems Manager (Telangana)
🏢 Synapmed
📍 Telangana