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 Specialist I &

• II – Pharmacovigilance Company: Syneos Health Department: Safety &

• Pharmacovigilance Location: Gurgaon / Hyderabad, India Employment Type: Full-Time (Office-Based) Job ID: 25110715 Experience Required: Safety &

• PV Specialist I: Minimum 2.6 Years

Safety & PV Specialist II: Minimum 4 Years Job Summary The Safety & PV Specialist I & II is responsible for end-to-end Individual Case Safety Report (ICSR) processing, safety data management, regulatory reporting support, literature review, medical coding activities, and compliance with global pharmacovigilance regulations. The role supports clinical trial and post-marketing safety activities by ensuring accurate, timely, and compliant safety reporting.

Key Responsibilities ICSR Processing & Case Management Enter safety case information into PV quality and tracking systems.

Process ICSRs according to SOPs, safety plans, and project-specific requirements.

Perform ICSR triage and evaluate cases for:

Completeness

Accuracy

Regulatory reportability

Enter case information into safety databases.

Code

Adverse events

Medical history

Concomitant medications

Laboratory tests

Prepare detailed and medically accurate case narratives.

Identify missing information and manage follow-up queries.

Identify and manage duplicate ICSRs.

Perform quality review of ICSRs.

Regulatory Reporting & Compliance Support preparation and submission of expedited safety reports according to global regulatory requirements.

Maintain safety tracking activities for assigned projects.

Ensure timely and accurate safety reporting.

Maintain compliance with

Standard Operating Procedures (SOPs)

Work Instructions (WIs)

GCP requirements

ICH guidelines

GVP requirements

Global drug, biologic, and medical device regulations

Medical Coding & Database Activities Perform MedDRA coding activities.

Support drug dictionary maintenance.

Perform literature screening and safety review.

Validate and submit xEVMPD product records.

Perform MedDRA coding of indication terms.

Perform manual recoding of uncoded product and substance terms.

Support SPOR / IDMP-related activities. Documentation & Quality Activities Ensure safety documents are filed in:

Trial Master File (TMF) for clinical trials

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

Maintain audit-ready safety documentation.

Participate in audits and inspection readiness activities.

Apply regulatory intelligence into safety reporting activities.

Stakeholder Collaboration Develop effective working relationships with:

Internal project teams

Sponsors





Cross-functional stakeholders

External partners

Support process improvement initiatives within pharmacovigilance operations.

Required Qualifications Educational Qualification Eligible Qualifications: B.Pharm

M.Pharm

BDS

BMS

MBBS Not Eligible: B.Sc

M.Sc Experience Requirements Safety & PV Specialist I Minimum 2.6 years of Pharmacovigilance experience. Safety & PV Specialist II Minimum 4 years of Pharmacovigilance experience.

Required Skills Strong understanding of ICSR lifecycle and safety reporting processes.

Knowledge of global pharmacovigilance regulations.

Experience with PV safety databases.

Knowledge of MedDRA coding.

Understanding of GCP, ICH guidelines, and GVP requirements.

Strong attention to detail and quality focus.

Excellent written and verbal communication skills.

Ability to manage multiple activities within strict timelines.

Preferred Experience Hands-on experience with Argus Safety, ARISg, or similar PV databases.

Experience in clinical trial safety and post-marketing surveillance.

Knowledge of xEVMPD, SPOR, and IDMP activities.

Experience in literature screening and safety coding.

Experience handling global safety cases.

Estimated Salary

Package (India) Safety &

• PV Specialist I (2.6+ Years Experience): ₹6 – ₹10 LPA Safety &

• PV Specialist II (4+ Years Experience): ₹9 – ₹15 LPA Higher packages may be offered for candidates with strong expertise in Argus Safety, MedDRA coding, global regulatory submissions, medical device PV, and complex case processing experience. Safety &

• PV Specialist I &

• II – Pharmacovigilance Company: Syneos Health Department: Safety &

• Pharmacovigilance Location: Gurgaon / Hyderabad, India Employment Type: Full-Time (Office-Based) Job ID: 25110715 Experience Required: Safety &

• PV Specialist I: Minimum 2.6 Years

Safety & PV Specialist II: Minimum 4 Years Key Responsibilities ICSR Processing & Case Management Enter safety case information into PV quality and tracking systems.

Process ICSRs according to SOPs, safety plans, and project-specific requirements.

Perform ICSR triage and evaluate cases for:

Completeness

Accuracy

Regulatory reportability

Enter case information into safety databases.

Code

Adverse events

Medical history

Concomitant medications

Laboratory tests

Prepare detailed and medically accurate case narratives.

Identify missing information and manage follow-up queries.

Identify and manage duplicate ICSRs.





Perform quality review of ICSRs.

Regulatory Reporting & Compliance Support preparation and submission of expedited safety reports according to global regulatory requirements.

Maintain safety tracking activities for assigned projects.

Ensure timely and accurate safety reporting.

Maintain compliance with

Standard Operating Procedures (SOPs)

Work Instructions (WIs)

GCP requirements

ICH guidelines

GVP requirements

Global drug, biologic, and medical device regulations

Medical Coding & Database Activities Perform MedDRA coding activities.

Support drug dictionary maintenance.

Perform literature screening and safety review.

Validate and submit xEVMPD product records.

Perform MedDRA coding of indication terms.

Perform manual recoding of uncoded product and substance terms.

Support SPOR / IDMP-related activities. Documentation & Quality Activities Ensure safety documents are filed in:

Trial Master File (TMF) for clinical trials

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

Maintain audit-ready safety documentation.

Participate in audits and inspection readiness activities.

Apply regulatory intelligence into safety reporting activities.

Stakeholder Collaboration Develop effective working relationships with:

Internal project teams

Sponsors

Cross-functional stakeholders

External partners

Support process improvement initiatives within pharmacovigilance operations.

Eligible Qualifications: B.Pharm

M.Pharm

BDS

BMS

MBBS Not Eligible: B.Sc

M.Sc Experience Requirements Safety & PV Specialist I Minimum 2.6 years of Pharmacovigilance experience. Safety & PV Specialist II Minimum 4 years of Pharmacovigilance experience.

Required Skills Robust understanding of ICSR lifecycle and safety reporting processes.

Knowledge of global pharmacovigilance regulations.

Experience with PV safety databases.

Knowledge of MedDRA coding.

Understanding of GCP, ICH guidelines, and GVP requirements.

Strong attention to detail and quality focus.

Excellent written and verbal communication skills.

Ability to manage multiple activities within strict timelines.

Preferred Experience Hands-on experience with Argus Safety, ARISg, or similar PV databases.

Experience in clinical trial safety and post-marketing surveillance.

Knowledge of xEVMPD, SPOR, and IDMP activities.

Experience in literature screening and safety coding.

Experience handling global safety cases.

Estimated Salary

Package (India) Safety & PV Specialist I (2.6+ Years Experience): ₹6 – ₹10 LPA Safety & PV Specialist II (4+ Years Experience): ₹9 – ₹15 LPA Higher packages may be offered for candidates with strong expertise in Argus Safety, MedDRA coding, global regulatory submissions, medical device PV, and complex case processing experience.

📌 Safety & PV Specialist I & II – Pharmacovigilance (India)
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