Job Title: Director, Safety and Pharmacovigilance (PV) – Technology (Innovation & AI Enablement Preferred)
Location: Yerawada, Maharashtra, India
Job ID: 25102967-OTHLOC-5448-2DH
Company: Syneos Health
Employment Type: Full-Time
Experience Required: 12–18+ years in Pharmacovigilance/Safety with 5+ years in technology transformation, digital innovation, or AI enablement leadership roles
About the Company
Syneos Health is a globally recognized, fully integrated biopharmaceutical solutions organization focused on accelerating customer success. By combining deep clinical development, medical affairs, and commercial expertise, the company delivers end-to-end solutions that bring therapies to patients faster. Operating across 110+ countries with over 29,000 professionals, Syneos Health supports the majority of recent novel drug approvals globally, including those authorized by the U.S. FDA and the EMA.
Role Overview
The Director, Safety and Pharmacovigilance (PV) – Technology will lead the design, implementation, and scaling of technology-enabled PV solutions. This strategic leadership role focuses on innovation, AI enablement, digital transformation, and operational excellence within global safety and pharmacovigilance ecosystems.
The position requires a hands-on leader capable of driving solution architecture, customer engagement, partner orchestration, and regulatory-compliant deployment across Safety and PV platforms.
Key Responsibilities
Own and execute the end-to-end Safety & PV technology roadmap covering:
Case intake and processing
Signal detection and management
Aggregate reporting and regulatory submissions
QPPV oversight
Literature monitoring
Safety analytics and advanced reporting
Lead cross-functional collaboration with internal IT teams, SaaS providers, and system integrators to ensure validated system deployment compliant with:
21 CFR Part 11
EU Annex 11
GAMP 5
Computer System Validation (CSV) standards
Serve as solution lead for RFIs/RFPs, including:
Reference architecture development
Delivery model design
Commercial structuring and cost estimation
Bid defense presentations
Establish and chair innovation councils with customers and partners; convert strategic problem statements into scalable pilot programs and AI-enabled Proof of Concepts (PoCs).
Act as a thought leader in PV technology by publishing whitepapers, speaking at industry conferences, hosting webinars, and briefing executive stakeholders on:
Artificial Intelligence (AI)
Natural Language Processing (NLP)
Robotic Process Automation (RPA)
Cloud-based PV systems
Real-world data (RWD) integration
Advanced analytics platforms
Manage a senior technology team; oversee portfolio governance, budget planning, resourcing strategy, and measurable ROI realization.
Embed risk-based quality, data privacy, cybersecurity, and compliance-by-design principles into all PV technology implementations.
Required Qualifications
Bachelor’s or Master’s degree in Life Sciences, Pharmacy, Medicine, Biotechnology, Computer Science, or related discipline; advanced degree preferred.
12–18+ years of experience in Pharmacovigilance or Drug Safety operations.
Minimum 5+ years in digital transformation, PV systems implementation, AI enablement, or technology strategy leadership.
Strong expertise in global regulatory safety frameworks.
Proven track record in leading validated PV system deployments.
Experience with AI-driven automation, safety analytics platforms, and innovation-led delivery models.
Demonstrated ability to lead global cross-functional teams and enterprise-scale initiatives.
Preferred Skills
Experience in AI/ML applications in Safety and Pharmacovigilance.
Exposure to cloud-based PV platforms and data lake environments.
Strong executive communication and customer-facing leadership capabilities.
Background in large CRO or biopharmaceutical service organizations.
Why Join Syneos Health
Global exposure across clinical development and safety innovation.
Leadership opportunity in AI-enabled pharmacovigilance transformation.
Strong focus on career progression, technical upskilling, and global collaboration.
Inclusive workplace culture promoting diversity, equity, and belonging.
Additional Information
This role may require additional responsibilities as assigned by the organization. Equivalent education and experience may be considered. The company is committed to global regulatory compliance, diversity, and equal opportunity employment practices.
Keywords: Director Pharmacovigilance Technology, Safety Systems Leader, AI in Drug Safety, PV Digital Transformation, Global Safety Operations, 21 CFR Part 11 Compliance, GAMP 5 Validation, PV Innovation Leadership, Clinical Safety Technology Jobs India, Pharmacovigilance Director Careers.
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Siliguri |Illinois :
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