Associate Director – Safety & Pharmacovigilance Job in Syneos Health

Syneos Health®, a global leader in biopharmaceutical solutions, is hiring an Associate Director – Safety and Pharmacovigilance for its Hyderabad office. This senior leadership role is ideal for experienced pharmacovigilance professionals with strong operational, people management, and client-facing expertise within a CRO or global safety environment.

As an Associate Director – Safety & PV, you will oversee end-to-end safety operations, manage teams, ensure regulatory compliance, and act as a key escalation point for sponsors. This position plays a strategic role in ensuring high-quality safety deliverables across clinical development programs.

🧠 Key Responsibilities – Associate Director Safety & Pharmacovigilance

• Serve as primary interface between Syneos Health, sponsors, vendors, and internal teams for Safety & PV services
• Provide line management to Safety and Pharmacovigilance associates and managers
• Oversee operational delivery aligned with Safety Management Plans (SMPs) and contracted scope
• Monitor quality, productivity, KPIs, and resolve below-target performance issues
• Lead PV-focused projects and ensure timely safety reporting submissions
• Review and approve study budgets, invoicing, and financial forecasts
• Act as escalation point for sponsors and provide regular project updates
• Coordinate with Clinical, Data Management, Regulatory, and other safety functions
• Develop, review, and approve SOPs, WIs, and process improvements
• Support Business Development, proposal reviews, and bid defenses
• Review safety sections of protocols, CRFs, and SAE forms
• Ensure compliance with ICH-GCP, GVP modules, global regulations, and internal SOPs
• Participate in audits, inspections, CAPAs, and inspection readiness activities
• Provide PV training and expert consultation to clients and internal teams

🎓 Qualifications & Experience Required

• Bachelor’s degree in Life Sciences, Pharmacy, Nursing, or Healthcare discipline
• Extensive experience in Safety & Pharmacovigilance leadership roles
• Proven people management and project management experience
• Prior CRO experience and therapeutic area exposure preferred
• Strong knowledge of GVP, ICH guidelines, clinical safety reporting
• Financial acumen for budget oversight and invoicing
• Proficiency in MS Word, Excel, PowerPoint, Visio, Outlook
• Excellent communication, stakeholder management, and presentation skills
• Ability to manage multiple priorities in a matrix, fast-paced environment

💼 Why Work at Syneos Health?

• Work with a company involved in 94% of FDA-approved novel drugs
• Exposure to global clients, complex safety programs, and cutting-edge technologies
• Strong focus on career development, leadership growth, and training
• Inclusive “Total Self” culture promoting diversity and belonging
• Opportunity to influence global pharmacovigilance strategy and operations

💰 Salary & Compensation (Indicative)

• ₹35,00,000 – ₹55,00,000 per annum (CTC)
• Performance-linked incentives and comprehensive benefits package

(Salary may vary based on experience, interview performance, and internal parity.)

📝 How to Apply – Associate Director Safety & PV

Application Link