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Director, Safety And Pv - Technology (Innovation & Ai Enablement Exp Preferred)

Syneos Health
Syneos Health
12-18+ years
Not Disclosed
Yerawada, India
10 Feb. 25, 2026
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

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.