Syneos Health®, a global biopharmaceutical solutions organization, is hiring an experienced Manager – Safety & Pharmacovigilance (ICSR) for its Hyderabad operations. This is a senior-level pharmacovigilance leadership role focused on ICSR management, people leadership, safety project oversight, and regulatory compliance within a CRO environment.
With operations across 110+ countries and involvement in nearly all recent FDA- and EMA-approved drugs, Syneos Health offers a strong platform for professionals seeking long-term growth in drug safety and pharmacovigilance careers.
🧠 Key Responsibilities – Safety & Pharmacovigilance Manager
As a Manager – Safety & Pharmacovigilance (ICSR), your responsibilities will include:
🔹 People & Line Management
- Lead and manage Safety team members, including hiring, onboarding, training, performance appraisals, utilization, and counseling
- Oversee workload distribution and ensure adherence to Safety Management Plans
- Mentor and develop pharmacovigilance professionals
🔹 Safety Project & ICSR Oversight
- Manage pharmacovigilance projects where Safety is the primary service
- Ensure high-quality case processing, compliance, and timely submissions
- Monitor team efficiency, quality metrics, and contractual deliverables
🔹 Financial & Client Management
- Review and approve study budgets, expenses, and invoicing
- Coordinate with Finance for accurate customer billing
- Provide regular safety updates and reports to sponsors and stakeholders
🔹 Regulatory & Compliance
- Ensure compliance with GVP modules, ICH guidelines, GCP, global PV regulations
- Review clinical protocols, CRFs, SAE forms, and safety sections of proposals
- Participate in audits, inspections, CAPA implementation, and inspection readiness
🔹 Process Improvement & Business Support
- Contribute to SOP development and process optimization
- Support Business Development activities, proposals, and bid defenses
- Represent Safety & Pharmacovigilance in internal and client meetings
🎓 Qualifications & Experience Required
To be eligible for this Manager Safety & Pharmacovigilance job, candidates should have:
- 8+ years of pharmacovigilance experience, including ICSR management
- 5+ years of people management / team leadership experience
- Bachelor’s degree (BA/BS) in Life Sciences, Biological Sciences, Healthcare, or Nursing
- Strong experience with ARGUS or ARISg Safety databases
- Advanced MS Excel skills (mandatory)
- Working knowledge of SQL / Power BI (preferred)
- CRO experience and exposure to multiple therapeutic areas
- Strong understanding of safety budgets, project management, and client communication
💼 Skills & Competencies
- Leadership and decision-making in a matrix environment
- Excellent written, verbal, and interpersonal communication
- Ability to manage multiple priorities in a fast-paced PV environment
- Proficiency in MS Word, Excel, PowerPoint, Outlook, and collaboration tools
🌟 Why Join Syneos Health?
- Work on 94% of FDA-approved and 95% of EMA-authorized products
- Global exposure across large, complex clinical development programs
- Strong focus on employee development, training, and career progression
- Inclusive Total Self culture promoting diversity, equity, and belonging
- Opportunity to lead high-impact pharmacovigilance projects
📌 Salary & Compensation (Estimated)
- ₹25,00,000 – ₹40,00,000 per annum (CTC)
- Salary may vary based on experience, skills, and interview performance
📩 How to Apply
