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 (valuable 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 (good 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) (India)
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