Manager – Safety & Pharmacovigilance (ICSR Management)
Job Requisition ID: 25103579
Employment Type: Full-Time
Work Mode: Office-Based
Location: Hyderabad, India
Experience Required: 8+ Years (Including 5+ Years in People Management)
Functional Area: Pharmacovigilance | Drug Safety | ICSR Management | Safety Operations
About the Company
Syneos Health® is a leading, fully integrated biopharmaceutical solutions organization committed to accelerating customer success. By combining clinical development, medical affairs, and commercial expertise, Syneos Health delivers high-impact solutions that address evolving global healthcare and regulatory challenges.
With a global workforce of over 29,000 professionals across 110+ countries, Syneos Health fosters a collaborative, inclusive, and performance-driven culture focused on improving patient safety and advancing drug development worldwide.
Position Overview
Syneos Health is seeking an experienced Manager – Safety & Pharmacovigilance (ICSR) to lead global safety operations and people management activities. This role is critical in overseeing ICSR processing, safety project delivery, regulatory compliance, client engagement, and team leadership within a dynamic CRO environment.
The ideal candidate will bring deep pharmacovigilance expertise, strong leadership capabilities, and hands-on experience managing safety teams, budgets, and client-facing safety programs.
Key Responsibilities
People & Resource Management
Provide line management to Safety & Pharmacovigilance team members, including hiring, onboarding, training, performance management, utilization, and professional development
Assign project workloads, monitor productivity, and ensure optimal resource utilization
Mentor team members and provide technical and operational guidance
Manage resourcing needs and escalate risks or gaps to senior leadership
Safety Operations & Project Oversight
Lead projects where Safety and Pharmacovigilance services are the primary scope
Oversee ICSR processing activities in alignment with Safety Management Plans (SMPs) and contractual obligations
Monitor quality, efficiency, and compliance of safety deliverables
Address below-target performance metrics and implement corrective actions
Financial & Client Management
Review and approve study budgets, expenses, timecards, and invoicing
Partner with Finance to ensure accurate client billing and financial tracking
Provide sponsors with regular project updates, metrics, and reports
Review and approve safety-related content in proposals, bid defenses, and budgets
Process, Compliance & Governance
Contribute to the development, review, and approval of Safety & PV SOPs and Work Instructions
Ensure compliance with global regulations including ICH-GCP, GVP modules, and local regulatory requirements
Review clinical safety sections of study protocols, CRFs, and SAE forms for consistency
Support audits, inspections, quality investigations, and CAPA implementation
Ensure inspection readiness across safety operations
Cross-Functional Collaboration
Coordinate with internal departments and functional teams to ensure timely safety submissions and issue resolution
Represent Safety & Pharmacovigilance in internal and client-facing meetings
Support Business Development activities and provide safety expertise during proposal development
Education & Experience Requirements
Education:
Bachelor’s degree in Biological Sciences, Life Sciences, Nursing, or a related healthcare discipline
Equivalent education and relevant experience will be considered
Experience:
Minimum 8+ years of experience in Pharmacovigilance / Drug Safety
At least 5+ years of experience in people management
Prior experience in a Clinical Research Organization (CRO) environment preferred
Technical & Professional Skills
Strong expertise in ICSR management and global safety reporting requirements
Hands-on experience with safety databases such as ARGUS or ARISg (preferred)
Advanced MS Excel proficiency
Working knowledge of financial budgeting and cost tracking
Exposure to SQL or Power BI is an advantage
Proficiency in MS Office (Word, Excel, PowerPoint), Visio, Outlook, and collaboration tools
Excellent written, verbal, and stakeholder communication skills
Proven leadership, decision-making, and project management capabilities
Ability to manage multiple priorities in a fast-paced, matrix environment
Why Join Syneos Health
Leadership opportunity in a globally recognized pharmacovigilance organization
Work on high-impact safety programs supporting innovative therapies
Collaborative culture with strong emphasis on professional growth
Exposure to global clients, regulatory agencies, and cross-functional teams
Equal Opportunity Statement
Syneos Health is an equal opportunity employer and complies with all applicable employment and accessibility regulations.
Apply now on thepharmadaily.com to advance your leadership career in Pharmacovigilance, Drug Safety, and Global Safety Operations.
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