Website:
synapmed.com
Job details:
Responsibilities
Managed Services & Support
- Lead incident, problem, and ticket management across client accounts
- Own RCA, SLA adherence, issue resolution, and service improvements
- Conduct governance reviews with IT, PV Ops, QA stakeholders
- Build SOPs, runbooks, and knowledge base articles
Configuration & System Management
- Configure workflows, reporting rules, user roles, interfaces, and scheduled jobs
- Manage product, study, and unblinding configurations
- Ensure RBAC, audit trails, and segregation of duties
- Convert business requirements into specs and test cases
Data Migration & Transitions
- Lead Argus / Vault / LifeSphere migrations and upgrades
- Manage mapping, cleansing, reconciliation, cutover, and fallback plans
- Oversee mock migrations, UAT, go-live, and final reports
Integrations & Regulatory Submissions
- Configure E2B(R2/R3) gateways for FDA, EMA, PMDA, MHRA, Health Canada
- Support integrations with EDC, CTMS, signal, literature, and document systems
- Manage MedDRA / WHO-Drug upgrades and impact analysis
Compliance, Validation & Audits
- Lead CSV / CSA documentation (URS, FRS, IQ/OQ/PQ, RTM, VSR)
- Ensure compliance with GAMP 5, 21 CFR Part 11, Annex 11, ALCOA+
- Own change control, CAPA, release governance, and validated state
- Support internal, client, and regulatory audits / inspections
Leadership & Stakeholder Management
- Lead and mentor global teams
- Provide technical direction and quality oversight
- Engage senior stakeholders as trusted advisor
- Drive workshops, solution design, and strategic initiatives
Required Skills
Domain Skills
- Strong Pharmacovigilance knowledge: AE/SAE/SUSAR, causality, seriousness, listedness
- End-to-end ICSR lifecycle expertise
- Knowledge of reports: PBRER, PSUR, DSUR, PADER, CIOMS, MedWatch
- Regulatory expertise: FDA, EMA, PMDA, ICH E2A/E2B/E2C/E2D/E2E
Systems Expertise
- Oracle Argus, ArisGlobal LifeSphere, Veeva Vault Safety
- Implementations, upgrades, managed services, migrations
- Signal tools: Empirica, LifeSphere Signal, Vault Signal
Technical Skills
- SQL / PL-SQL
- XML, log analysis, troubleshooting
- APIs, middleware, gateways, integrations
- ServiceNow, Jira, HP ALM, Azure DevOps
Compliance Skills
- CSV / CSA lifecycle
- GAMP 5, ALCOA+, eQMS, CAPA, change control
- Audit readiness and remediation management
Modern Skills
- AI / Automation in PV: GenAI, auto-coding, duplicate detection, signal detection
- Leadership, communication, consulting, multitasking
Tools & Technologies
Safety Systems
- Oracle Argus Safety
- ArisGlobal LifeSphere Safety / agXchange
- Veeva Vault Safety
Signal & Literature
- Oracle Empirica Signal
- LifeSphere Signal
- Vault Signal
- Embase, PubMed, EMA MLM
Databases & Integrations
- Oracle DB
- SQL / PL-SQL
- XML
- REST / SOAP APIs
- Middleware / ESB
- EDC / CTMS integrations
Compliance & ITSM
- ServiceNow
- Jira
- HP ALM
- Azure DevOps
- Veeva Vault QMS
- TrackWise
- MasterControl
Collaboration
- Microsoft Teams
- SharePoint
- Confluence
AI & Automation
- GenAI / LLM tools
- Auto-coding engines
- UiPath / Power Automate
- AI-assisted ITSM
Education & Experience
- Bachelor’s degree in Pharmacy, Life Sciences, Computer Science, or related field
- Master’s degree / MBA preferred
- 6–10+ years of experience in PV systems / Pharma / CRO / Consulting
- Experience leading global teams and client programs
- Certifications (ITIL, GAMP, Oracle/Veeva/ArisGlobal) preferred
Special Conditions
- Willingness to work flexible hours across EU / US / APAC time zones
- Availability for audits, inspections, cutovers, and critical incidents on short notice
- Travel for client meetings, go-lives, and audits as needed
- Comfortable acting as senior technical SME in leadership discussions
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