Job Title: Director, Safety and Pharmacovigilance (PV) – Technology (Innovation & AI Enablement Preferred)
Location: Madhapur, Telangana, India
Job ID: 25102967-OTHLOC-5449-2DH
Company: Syneos Health
Employment Type: Full-Time
Experience Required: 12–18+ years in Pharmacovigilance/Drug Safety with minimum 5+ years in PV technology, digital transformation, or AI-driven innovation leadership
About the Company
Syneos Health is a leading, fully integrated biopharmaceutical solutions organization dedicated to accelerating customer success. By combining clinical development, medical affairs, and commercial capabilities, the company delivers patient-centered, technology-enabled solutions across the drug development lifecycle. With 29,000+ employees across 110+ countries, Syneos Health has contributed to the majority of recent global novel drug approvals, supporting both U.S. FDA and EMA-authorized products.
Role Overview
The Director, Safety and PV – Technology will serve as a strategic and operational leader responsible for building, scaling, and delivering technology-enabled Pharmacovigilance (PV) solutions. This role is focused on innovation, AI enablement, automation, and digital transformation within global safety operations.
The position requires strong leadership across internal IT, SaaS vendors, and system integrators while ensuring compliance, quality, and measurable business value in PV system implementations.
Key Responsibilities
Own and execute the end-to-end Safety and Pharmacovigilance technology roadmap, including:
Case intake and case processing
Signal detection and risk management
Aggregate reporting and regulatory submissions
QPPV oversight
Literature monitoring
Safety data analytics and reporting
Lead cross-functional program execution with internal teams and external technology partners; establish governance frameworks, SLAs, KPIs, and validated system deployments aligned with:
21 CFR Part 11
EU Annex 11
GAMP 5
Computer System Validation (CSV) standards
Act as solution lead for RFIs and RFPs by developing:
Reference architectures
Delivery and operating models
Scope definitions and cost estimations
Commercial strategies and bid defense presentations
Convene and chair innovation councils with customers and partners; convert business challenges into pilot programs and AI-driven Proof of Concepts (PoCs) with defined success metrics.
Represent the organization as a thought leader in PV technology by publishing whitepapers, speaking at industry conferences, leading webinars, and briefing executives on emerging trends such as:
Artificial Intelligence (AI)
Natural Language Processing (NLP)
Robotic Process Automation (RPA)
Cloud-based safety systems
Real-world data integration
Advanced analytics platforms
Lead and mentor a senior technology team; manage portfolio planning, budget allocation, resource strategy, and measurable ROI realization.
Embed risk-based quality, data privacy, cybersecurity, and compliance-by-design principles into all technology implementations.
Required Qualifications
Bachelor’s or Master’s degree in Pharmacy, Life Sciences, Biotechnology, Medicine, Computer Science, or related field. Advanced degree preferred.
12–18+ years of experience in Drug Safety or Pharmacovigilance operations.
Minimum 5+ years of leadership experience in PV systems implementation, digital innovation, or AI enablement initiatives.
Strong knowledge of global pharmacovigilance regulations and compliance frameworks.
Demonstrated expertise in validated PV system deployment and governance.
Experience leading global cross-functional and vendor ecosystems.
Preferred Skills
Hands-on exposure to AI/ML applications within drug safety.
Experience with cloud-based PV platforms and data transformation programs.
Strong executive communication and client engagement capabilities.
Prior experience within CRO or global biopharmaceutical service organizations.
Why Join Syneos Health
Leadership opportunity in AI-driven pharmacovigilance transformation.
Exposure to global clinical development and regulatory innovation.
Strong focus on career growth, training, and technical advancement.
Inclusive, diverse, and collaborative work culture.
Additional Information
Responsibilities listed are not exhaustive and may evolve based on business requirements. Equivalent qualifications and experience may be considered. The organization is committed to global regulatory compliance, diversity, equity, inclusion, and equal opportunity employment practices.
SEO Keywords: Director Pharmacovigilance Technology, Safety Systems Director India, AI in Drug Safety, PV Digital Transformation Jobs, 21 CFR Part 11 Compliance, GAMP 5 Validation, Pharmacovigilance Leadership Roles, Global Safety Technology Careers, Drug Safety Innovation Jobs Hyderabad, PV AI Enablement Director.
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