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: Hyderabad, India Work Location: Office-Based Employment Type: Full-Time 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 role is responsible for Individual Case Safety Report (ICSR) processing, safety data management, regulatory reporting support, medical coding, literature review, and pharmacovigilance compliance activities. The role ensures accurate, timely, and compliant safety reporting in accordance with global regulatory requirements, company SOPs, and project-specific safety plans.

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

Process ICSRs according to Standard Operating Procedures (SOPs) and project-specific safety plans.

Perform ICSR triage and evaluate case data for:

Completeness

Accuracy

Regulatory reportability

Enter case information into safety databases.

Perform coding activities for

Adverse events

Medical history

Concomitant medications

Laboratory tests

Prepare complete and medically accurate narrative summaries.

Identify missing or inconsistent information and manage follow-up queries until resolution.

Identify and manage duplicate ICSRs.

Perform quality review of ICSRs.

Regulatory Reporting & Compliance Support generation of timely, consistent, and accurate expedited safety reports.

Maintain safety tracking activities for assigned projects.

Ensure compliance with

Global pharmacovigilance regulations

GCP requirements

ICH guidelines

GVP guidelines

Drug, biologic, and medical device safety regulations

Apply safety reporting regulatory intelligence to assigned activities.

Participate in audits and inspection readiness activities.

Medical Coding & Safety Database Activities Perform MedDRA coding activities.

Support drug dictionary maintenance.

Perform literature screening and safety review.

Validate and submit xEVMPD product records.

Perform appropriate MedDRA coding of indication terms.

Conduct manual recoding of uncoded product and substance terms from ICSRs.

Support SPOR / IDMP-related activities.

Documentation Management

Ensure safety documents are submitted and maintained in:

Trial Master File (TMF) for clinical trials

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

Maintain accurate safety documentation according to sponsor requirements and company SOPs.

Support quality and compliance documentation activities.

Stakeholder Collaboration Develop qualified working relationships with:

Project teams

Internal stakeholders

External partners

Sponsors





Collaborate effectively to ensure timely completion of PV activities.

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.

Experience in ICSR processing and safety database activities. Safety & PV Specialist II Minimum 4 years of pharmacovigilance experience.

Solid experience in case processing, quality review, and regulatory safety activities.

Required Skills Strong understanding of the pharmacovigilance lifecycle.

Hands-on experience with ICSR processing.

Knowledge of MedDRA coding.

Understanding of global PV regulations.

Knowledge of GCP, ICH, and GVP requirements.

Strong attention to detail and quality focus.

Ability to manage multiple cases and deadlines.

Good written and verbal communication skills.

Proficiency in Microsoft Office applications.

Preferred Experience Experience with Argus Safety, ARISg, or similar pharmacovigilance databases.

Experience in clinical trial safety and post-marketing surveillance.

Knowledge of

xEVMPD

SPOR

IDMP processes

Experience with literature screening and drug coding.

Experience handling complex 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 Candidates with strong Argus expertise, MedDRA coding experience, global case processing exposure, and regulatory submission knowledge may receive higher compensation packages. Safety &

• PV Specialist I &

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

• Pharmacovigilance Location: Hyderabad, India Work Location: Office-Based Employment Type: Full time 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 for receipt and tracking of ICSRs.

Process ICSRs according to Standard Operating Procedures (SOPs) and project-specific safety plans.

Perform ICSR triage and evaluate case data for:

Completeness

Accuracy

Regulatory reportability

Enter case information into safety databases.

Perform coding activities for

Adverse events

Medical history

Concomitant medications

Laboratory tests

Prepare complete and medically accurate narrative summaries.

Identify missing or inconsistent information and manage follow-up queries until resolution.

Identify and manage duplicate ICSRs.





Perform quality review of ICSRs.

Regulatory Reporting & Compliance Support generation of timely, consistent, and accurate expedited safety reports.

Maintain safety tracking activities for assigned projects.

Ensure compliance with

Global pharmacovigilance regulations

GCP requirements

ICH guidelines

GVP guidelines

Drug, biologic, and medical device safety regulations

Apply safety reporting regulatory intelligence to assigned activities.

Participate in audits and inspection readiness activities.

Medical Coding & Safety Database Activities Perform MedDRA coding activities.

Support drug dictionary maintenance.

Perform literature screening and safety review.

Validate and submit xEVMPD product records.

Perform appropriate MedDRA coding of indication terms.

Conduct manual recoding of uncoded product and substance terms from ICSRs.

Support SPOR / IDMP-related activities.

Documentation Management

Ensure safety documents are submitted and maintained in:

Trial Master File (TMF) for clinical trials

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

Maintain accurate safety documentation according to sponsor requirements and company SOPs.

Support quality and compliance documentation activities.

Stakeholder Collaboration Develop professional working relationships with:

Project teams

Internal stakeholders

External partners

Sponsors

Collaborate effectively to ensure timely completion of PV activities.

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.

Experience in ICSR processing and safety database activities. Safety & PV Specialist II Minimum 4 years of pharmacovigilance experience.

Strong experience in case processing, quality review, and regulatory safety activities.

Required Skills Strong understanding of the pharmacovigilance lifecycle.

Hands-on experience with ICSR processing.

Knowledge of MedDRA coding.

Understanding of global PV regulations.

Knowledge of GCP, ICH, and GVP requirements.

Strong attention to detail and quality focus.

Ability to manage multiple cases and deadlines.

Good written and verbal communication skills.

Proficiency in Microsoft Office applications.

Preferred Experience Experience with Argus Safety, ARISg, or similar pharmacovigilance databases.

Experience in clinical trial safety and post-marketing surveillance.

Knowledge of

xEVMPD

SPOR

IDMP processes

Experience with literature screening and drug coding.

Experience handling complex 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 Candidates with strong Argus expertise, MedDRA coding experience, global case processing exposure, and regulatory submission knowledge may receive higher compensation packages.

📌 Safety & PV Specialist I & II (Hyderabad)
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