06 Aug
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Budaun
06 Aug
The Pharma Daily - Powered by Vigisolvo
Budaun
Job Type: Full Time, Hybrid, Remote Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: ICH guidelines, ICSR Case Processing, Labelling Assessment, MedDRA Coding, mRS and EQ-5D-5L, Triage of ICSRs, WHO DD Coding
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.
Experience Requirements Required Qualifications & Experience
- 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.
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 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.
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
Preferred Experience With:
- ARGUS Safety Database
- ARISg Safety Database
- Advanced Microsoft Excel skills
- SQL knowledge (positive to have)
- Power BI knowledge (good to have)
Proficiency In:
- Microsoft Word
- Microsoft Excel
- Microsoft PowerPoint
- Visio
- Outlook
- TeamShare / document management platforms
- Internet-based systems
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
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.
📌 Manager - Safety & PV (ICSR) (Budaun)
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