06 Aug
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The Pharma Daily - Powered by Vigisolvo
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Hyderabad
06 Aug
The Pharma Daily - Powered by Vigisolvo
Hyderabad
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
- Valuable organizational skills
- Ability to meet deadlines
- Independent working ability
- Strong 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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