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 Safety & PV Coordinator (Hyderabad Office-Based) Company: Syneos Health Location: Hyderabad, India Office Location: Hyderabad Job ID: 25110587 Updated: July 29, 2026 Employment Type: Full-Time Work Mode: Office-Based About Syneos Health Syneos Health® is a leading fully integrated life sciences services organization built to accelerate customer success. The company partners with innovators across the drug development and commercialization continuum, helping them navigate complexity, anticipate change, and accelerate progress.

Syneos Health Provides Solutions Across: Clinical development

Medical affairs

Commercial services

Patient-focused healthcare innovation Job Summary The Safety & PV Coordinator is responsible for supporting pharmacovigilance operations, including: Individual Case Safety Report (ICSR) processing

Safety database management

Regulatory reporting support

Medical coding activities

Literature review

Post-marketing surveillance (PMS) case handling

Compliance with global safety regulations Key Responsibilities ICSR Processing & Case Management Enter information into PVG quality and tracking systems for receipt and tracking of ICSRs.

Process ICSRs according to

Standard Operating Procedures (SOPs)

Project-specific safety plans

Triage ICSRs and evaluate

Completeness

Accuracy

Regulatory reportability

Enter data into safety databases.

Code

Adverse events

Medical history

Concomitant medications

Medical tests

Prepare complete and accurate narrative summaries.

Identify missing information and follow up on queries until resolution.

Support timely generation of expedited safety reports.

Safety Data Management Activities Maintain safety tracking for assigned activities.

Perform

Literature screening

Safety review

Drug coding

Drug dictionary maintenance

MedDRA coding

Perform validation and submission of:

xEVMPD product records

Indication term coding using MedDRA

Perform manual recoding of

Uncoded product terms

Uncoded substance terms from ICSRs

Identify and manage duplicate ICSRs.

Support SPOR / IDMP activities.

Perform quality review of ICSRs.

Regulatory Compliance & Documentation Ensure submission of relevant documents to:

Trial Master File (TMF) for clinical trials

Pharmacovigilance System Master File (PSMF) for post-marketing programs

Maintain compliance with

SOPs

Work Instructions (WIs)

GCP

ICH guidelines

GVP requirements

Drug, biologic, and device regulations

Participate in audits when required.

Apply safety reporting regulatory intelligence to assigned activities.

Collaboration & Communication Build effective working relationships with:

Internal project teams

External stakeholders

Clients

Communicate safety-related information clearly.





Work independently and collaboratively within project teams.

Required Qualifications Education Required: B.Pharm

M.Pharm Experience Requirements Minimum 1 year of experience in:

Post-Marketing Surveillance (PMS)

Spontaneous case processing

Technical Skills & Knowledge Preferred safety databases: LSMV

Argus experience acceptable Required Knowledge: Safety database systems

Medical terminology

Clinical trial processes (Phase II–IV)

Post-marketing safety requirements

ICH-GCP guidelines

GVP regulations

Pharmacovigilance regulations Software Skills Proficiency in: Microsoft Word

Microsoft Excel

Microsoft PowerPoint

Visio

Outlook email

Team Share / document management platforms

Internet-based systems Key Competencies Strong attention to detail and accuracy

Ability to manage multiple tasks and priorities

Good organizational skills

Ability to meet deadlines

Independent working ability

Robust written and verbal communication skills

Effective teamwork and collaboration skills 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 Syneos Health Focuses On: Career development

Technical training

Inclusive culture

Global collaboration Application Information Position: Safety & PV Coordinator Location: Hyderabad, India Qualification: B.Pharm / M.Pharm Experience: Minimum 1 year PMS & Spontaneous Case experience Database Preference: LSMV / Argus Apply through the Syneos Health careers portal. Safety & PV Coordinator (Hyderabad Office-Based) Company: Syneos Health Location: Hyderabad, India Office Location: Hyderabad Job ID: 25110587 Updated: July 29, 2026 Employment Type: Full-Time Work Mode: Office-Based Syneos Health Provides Solutions Across: Clinical development

Medical affairs

Commercial services

Patient-focused healthcare innovation Job Summary The Safety & PV Coordinator is responsible for supporting pharmacovigilance operations, including: Individual Case Safety Report (ICSR) processing

Safety database management

Regulatory reporting support

Medical coding activities

Literature review

Post-marketing surveillance (PMS) case handling

Compliance with global safety regulations Key Responsibilities ICSR Processing & Case Management Enter information into PVG quality and tracking systems for receipt and tracking of ICSRs.

Process ICSRs according to

Standard Operating Procedures (SOPs)

Project-specific safety plans

Triage ICSRs and evaluate

Completeness

Accuracy





Regulatory reportability

Enter data into safety databases.

Code

Adverse events

Medical history

Concomitant medications

Medical tests

Prepare complete and accurate narrative summaries.

Identify missing information and follow up on queries until resolution.

Support timely generation of expedited safety reports.

Safety Data Management Activities Maintain safety tracking for assigned activities.

Perform

Literature screening

Safety review

Drug coding

Drug dictionary maintenance

MedDRA coding

Perform validation and submission of:

xEVMPD product records

Indication term coding using MedDRA

Perform manual recoding of

Uncoded product terms

Uncoded substance terms from ICSRs

Identify and manage duplicate ICSRs.

Support SPOR / IDMP activities.

Perform quality review of ICSRs.

Regulatory Compliance & Documentation Ensure submission of relevant documents to:

Trial Master File (TMF) for clinical trials

Pharmacovigilance System Master File (PSMF) for post-marketing programs

Maintain compliance with

SOPs

Work Instructions (WIs)

GCP

ICH guidelines

GVP requirements

Drug, biologic, and device regulations

Participate in audits when required.

Apply safety reporting regulatory intelligence to assigned activities.

Collaboration & Communication Build effective working relationships with:

Internal project teams

External stakeholders

Clients

Communicate safety-related information clearly.

Work independently and collaboratively within project teams.

Required: B.Pharm

M.Pharm Experience Requirements Minimum 1 year of experience in:

Post-Marketing Surveillance (PMS)

Spontaneous case processing

Preferred Safety Databases: LSMV

Argus experience acceptable Required Knowledge: Safety database systems

Medical terminology

Clinical trial processes (Phase II–IV)

Post-marketing safety requirements

ICH-GCP guidelines

GVP regulations

Pharmacovigilance regulations Proficiency In: Microsoft Word

Microsoft Excel

Microsoft PowerPoint

Visio

Outlook email

Team Share / document management platforms

Internet-based systems Key Competencies Strong attention to detail and accuracy

Ability to manage multiple tasks and priorities

Good organizational skills

Ability to meet deadlines

Independent working ability

Strong written and verbal communication skills

Effective teamwork and collaboration skills 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 Syneos Health Focuses On: Career development

Technical training

Inclusive culture

Global collaboration Application Information Position: Safety & PV Coordinator Location: Hyderabad, India Qualification: B.Pharm / M.Pharm Experience: Minimum 1 year PMS & Spontaneous Case experience Database Preference: LSMV / Argus Apply through the Syneos Health careers portal.

📌 Safety & PV Coordinator (Hyderabad Office-based)
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