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 Job Title: Senior Safety &

• Pharmacovigilance (PV) Specialist Discover more Health Libraries Computer Science Company: Syneos Health Location: Gurugram / Hyderabad, India (Office-based) Job ID: 25107898 Employment Type: Full time Department: Safety &

• Pharmacovigilance Operations Experience Required: Minimum 6+ years of Pharmacovigilance experience with strong expertise in ICSR case processing, quality review (QC), safety database management, and regulatory safety reporting. Discover more Pharmacy Job Dictionaries &

• Encyclopedias Occupational Health &

• Safety Education: B.Pharm / M.Pharm / BDS / BMS / MBBS (B.Sc/M.Sc not eligible) Salary Package: ₹12–22 LPA (Estimated as per current market standards for Senior Safety &

• PV Specialist roles in India; final compensation depends on ICSR processing expertise, QC experience, regulatory exposure, and interview performance.) Role Summary The Senior Safety &

• PV Specialist will manage end-to-end Individual Case Safety Report (ICSR) processing activities, ensure quality and regulatory compliance, perform safety data review, and support global Pharmacovigilance operations according to ICH-GCP, GVP, and regulatory requirements.

Key Responsibilities ICSR Case Processing & Safety Database Management Enter and manage safety case information in Pharmacovigilance quality and tracking systems.

Process ICSRs according to

Company SOPs

Safety Management Plans

Regulatory requirements

Perform ICSR triage and evaluate:

Completeness

Accuracy

Regulatory reportability

Enter safety data into PV databases.

Code

Adverse events

Medical history

Concomitant medications

Laboratory tests

Safety Data Review & Quality Control Perform Quality Control (QC) review of ICSRs.

Ensure accuracy, consistency, and compliance of safety reports.

Identify missing information and generate follow-up queries.

Track query resolution until completion.

Identify and manage duplicate safety cases.

Perform manual recoding of un-coded product and substance terms.

Regulatory Safety Reporting

Support preparation and submission of expedited safety reports.

Ensure timely and accurate regulatory submissions.

Apply global safety reporting requirements and regulatory intelligence.

Maintain compliance with

FDA regulations

EMA requirements

ICH guidelines

GVP guidelines

Medical Coding & Literature Review Perform literature screening and safety review activities.

Conduct

MedDRA coding

Drug coding

Medical terminology review

Maintain drug dictionaries and coding standards.

Support xEVMPD product record validation and submissions.

Perform indication coding using MedDRA.

SPOR / IDMP Activities Support activities related to:

SPOR data management

Identification of Medicinal Products (IDMP)

Ensure product and substance data accuracy.





Documentation & Compliance Ensure safety documents are filed correctly in:

Trial Master File (TMF)

Pharmacovigilance System Master File (PSMF)

Participate in

Internal audits

Client audits

Quality reviews

Maintain compliance with

SOPs

Work Instructions

GCP

ICH Guidelines

GVP Regulations

Global drug/biologic/device regulations

Required Technical Skills Individual Case Safety Report (ICSR) Processing

ICSR Quality Control (QC)

Pharmacovigilance Operations

Safety Database Management

Adverse Event Coding

MedDRA Coding

Drug Dictionary Management

Literature Screening

Regulatory Safety Reporting xEVMPD Product Records

SPOR / IDMP Knowledge

TMF Filing

GVP & ICH Guidelines Mandatory Skills Minimum 6 years of Pharmacovigilance experience Strong ICSR case processing experience Hands-on Quality Check (QC) experience mandatory Knowledge of global PV regulations Preferred Experience Experience with safety databases preferred CRO experience preferred.

Global clinical trial safety experience.

Exposure to post-marketing safety activities.

Experience working with multinational pharmaceutical clients.

Key Competencies

Strong attention to detail.

Excellent analytical and problem-solving skills.

Ability to manage complex safety cases.

Strong written and verbal communication skills.

Ability to work independently and collaboratively.

Good understanding of drug development processes.

Work Location Gurugram / Hyderabad (Office-based) Career Opportunity Opportunity to work on global Pharmacovigilance programs.

Exposure to international regulatory frameworks.

Growth opportunities within Clinical Safety and PV operations.

Collaboration with global pharmaceutical and biotech teams.

Job Title: Senior Safety &

• Pharmacovigilance (PV) Specialist Discover more Health Libraries Computer Science Company: Syneos Health Location: Gurugram / Hyderabad, India (Office-based) Job ID: 25107898 Employment Type: Full-time Department: Safety &

• Pharmacovigilance Operations Experience Required: Minimum 6+ years of Pharmacovigilance experience with strong expertise in ICSR case processing, quality review (QC), safety database management, and regulatory safety reporting. Discover more Pharmacy Job Dictionaries &

• Encyclopedias Occupational Health &

• Safety Education: B.Pharm / M.Pharm / BDS / BMS / MBBS (B.Sc/M.Sc not eligible) Salary Package: ₹12–22 LPA (Estimated as per current market standards for Senior Safety &

• PV Specialist roles in India; final compensation depends on ICSR processing expertise, QC experience, regulatory exposure, and interview performance.) Key Responsibilities ICSR Case Processing &





• Safety Database Management Enter and manage safety case information in Pharmacovigilance quality and tracking systems.

Process ICSRs according to

Company SOPs

Safety Management Plans

Regulatory requirements

Perform ICSR triage and evaluate:

Completeness

Accuracy

Regulatory reportability

Enter safety data into PV databases.

Code

Adverse events

Medical history

Concomitant medications

Laboratory tests

Safety Data Review & Quality Control Perform Quality Control (QC) review of ICSRs.

Ensure accuracy, consistency, and compliance of safety reports.

Identify missing information and generate follow-up queries.

Track query resolution until completion.

Identify and manage duplicate safety cases.

Perform manual recoding of un-coded product and substance terms.

Regulatory Safety Reporting

Support preparation and submission of expedited safety reports.

Ensure timely and accurate regulatory submissions.

Apply global safety reporting requirements and regulatory intelligence.

Maintain compliance with

FDA regulations

EMA requirements

ICH guidelines

GVP guidelines

Medical Coding & Literature Review Perform literature screening and safety review activities.

Conduct

MedDRA coding

Drug coding

Medical terminology review

Maintain drug dictionaries and coding standards.

Support xEVMPD product record validation and submissions.

Perform indication coding using MedDRA.

SPOR / IDMP Activities Support activities related to:

SPOR data management

Identification of Medicinal Products (IDMP)

Ensure product and substance data accuracy.

Documentation & Compliance Ensure safety documents are filed correctly in:

Trial Master File (TMF)

Pharmacovigilance System Master File (PSMF)

Participate in

Internal audits

Client audits

Quality reviews

Maintain compliance with

SOPs

Work Instructions

GCP

ICH Guidelines

GVP Regulations

Global drug/biologic/device regulations

Required Technical Skills Individual Case Safety Report (ICSR) Processing

ICSR Quality Control (QC)

Pharmacovigilance Operations

Safety Database Management

Adverse Event Coding

MedDRA Coding

Drug Dictionary Management

Literature Screening

Regulatory Safety Reporting xEVMPD Product Records

SPOR / IDMP Knowledge

TMF Filing

GVP & ICH Guidelines Preferred Experience CRO experience preferred.

Global clinical trial safety experience.

Exposure to post-marketing safety activities.

Experience working with multinational pharmaceutical clients.

Key Competencies

Strong attention to detail.

Excellent analytical and problem-solving skills.

Ability to manage complex safety cases.

Strong written and verbal communication skills.

Ability to work independently and collaboratively.

Good understanding of drug development processes.

Work Location Gurugram / Hyderabad (Office-based) Career Opportunity Opportunity to work on global Pharmacovigilance programs.

Exposure to international regulatory frameworks.

Growth opportunities within Clinical Safety and PV operations.

Collaboration with global pharmaceutical and biotech teams.

📌 Sr Safety & PV Specialist (Gurugram)
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