Manager - Safety & PV (ICSR)
Company: Syneos Health
Location: Gurgaon, India
Job ID: 25110716
Updated: July 28, 2026
Work Area: Safety & Pharmacovigilance
Role Type: Manager – ICSR Operations
About Syneos Health
Syneos Health® is a leading fully integrated biopharmaceutical solutions organization focused on accelerating customer success across the drug development and commercialization continuum.
The company combines expertise in:
Clinical development
Medical affairs
Commercial solutions
Pharmacovigilance services
Syneos Health operates globally with teams working together to support healthcare innovation.
Job Summary
The Manager - Safety & PV (ICSR) is responsible for:
Leading Safety & Pharmacovigilance operations
Managing ICSR-related activities
Driving quality and compliance
Managing safety project delivery
Leading and developing safety teams
Ensuring adherence to global PV regulations and client requirements
Key Responsibilities
People Management & Team Leadership
Manage team operations including:
Hiring
Employee transfers
Resource utilization
Training
Professional development
Performance evaluations
Timesheet approvals
Employee counseling
Provide guidance on:
Administrative processes
Technical issues
Work prioritization
Assign project work and monitor workload distribution.
Provide direction aligned with organizational goals and company objectives.
Mentor Safety team members and support career development.
Project & Safety Operations Management
Manage projects where Safety & Pharmacovigilance are primary services.
Monitor quality and efficiency of safety teams against:
Contract scope
Safety Management Plans
Project objectives
Review study budgets and expenses.
Ensure contractual and financial commitments are fulfilled.
Coordinate:
Customer invoicing
Project timecards
Financial tracking
Provide sponsors with:
Project updates
Status reports
Safety deliverables
Safety Department Management
Support department-level activities including:
Development, review, and approval of Safety SOPs.
Review and execution of:
Safety Management Plans
Safety Reporting Plans
Evaluate processes and recommend improvements.
Drive efficiency and process optimization.
Support business development activities when required.
Represent Safety & Pharmacovigilance in:
Internal meetings
Client meetings
Project discussions
Clinical & Regulatory Responsibilities
Review and approve Safety sections of project proposals.
Participate in bid defense meetings.
Review clinical safety sections of:
Study protocols
Case Report Forms (CRFs)
Serious Adverse Event documentation
Approve project budget projections.
Ensure compliance with:
SOPs
Work Instructions (WIs)
Global drug/biologic/device regulations
GCP requirements
ICH guidelines
GVP modules
Study plans
Training & Quality Management
Identify training requirements.
Develop and deliver training programs for:
Safety teams
Other Syneos departments
Manage resource requirements and escalate issues when required.
Participate in:
Audits
Regulatory inspections
Quality investigations
Support implementation of:
Corrective and Preventive Actions (CAPA)
Maintain inspection readiness.
Required Qualifications & Experience
Experience Requirements
Minimum 10+ years of Pharmacovigilance experience
Minimum 5+ years of People Management experience
Clinical Research Organization (CRO) experience preferred
Experience managing therapeutic-area safety projects preferred
Educational Qualification
Required:
BA/BS degree in:
Biological sciences
Natural sciences
Healthcare-related disciplines
OR
Nursing degree
Equivalent combination of education and experience
Technical Skills
Preferred experience with:
ARGUS Safety Database
ARISg Safety Database
Advanced Microsoft Excel skills
SQL knowledge (good to have)
Power BI knowledge (good to have)
Software Skills
Proficiency in:
Microsoft Word
Microsoft Excel
Microsoft PowerPoint
Visio
Outlook
TeamShare / document management platforms
Internet-based systems
Leadership & Behavioral Skills
Strong ability to:
Lead and motivate teams
Manage multiple priorities
Make effective decisions
Work independently and in a matrix environment
Adapt to changing business needs
Build client and team relationships
Communicate effectively with stakeholders
Deliver high-quality work under deadlines
About Syneos Health
Syneos Health has supported:
94% of Novel FDA Approved Drugs
95% of EMA Authorized Products
200+ studies across 73,000 sites
675,000+ clinical trial patients
The company emphasizes:
Career development
Technical training
Employee recognition
Inclusive workplace culture
Global collaboration
Application Details
Position: Manager - Safety & PV (ICSR)
Location: Gurgaon, India
Experience Required: 10+ years PV experience | 5+ years people management
Preferred Skills: ARGUS / ARISg, Excel, SQL, Power BI
Apply through the Syneos Health careers portal.
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