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 - PQC Company: Syneos Health Location: Gurgaon, India Job ID: 25107950 Employment Type: Full-Time Work Mode: Office-Based Experience Required: 2.5 – 4 Years About Syneos Health Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. The company partners with innovators across the drug development and commercialization continuum, helping navigate complexity and accelerate progress.

Syneos Health Focuses On: Clinical development solutions

Medical affairs

Commercial insights

Patient-focused healthcare innovation Job Summary The Safety & Pharmacovigilance Specialist I – Medical Device & PQC is responsible for: End-to-end Individual Case Safety Report (ICSR) processing

Safety data management

Regulatory reporting support

Compliance with global pharmacovigilance regulations

Product Quality Complaint (PQC) case handling

Medical research-related safety case processing 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) and project-specific safety plans.

Triage ICSRs and evaluate

Completeness

Accuracy

Regulatory reportability

Enter case data into safety databases such as:

Argus

ARISg

Perform coding of

Adverse events

Medical history

Concomitant medications

Laboratory tests

Code using

MedDRA

Relevant medical dictionaries

Prepare accurate medical narrative summaries.

Identify missing or inconsistent information.

Follow up on queries until resolution.

Identify and manage duplicate ICSRs.

Perform quality review of ICSRs.

Regulatory Reporting & Compliance Support preparation and submission of expedited safety reports.

Ensure reporting activities comply with global regulatory requirements.

Validate and submit xEVMPD product records.

Perform MedDRA coding of indication terms.

Perform manual recoding of uncoded product and substance terms.

Support SPOR / IDMP activities.

Maintain safety tracking activities.

Ensure documentation submission to

Trial Master File (TMF)

Pharmacovigilance System Master File (PSMF)

Apply safety reporting regulatory intelligence.

Maintain compliance with

SOPs

Work Instructions (WIs)

GCP

ICH guidelines

GVP regulations

Global drug, biologic, and device regulations

Literature,



Audit & Collaboration Perform literature screening and safety reviews.

Maintain drug dictionaries.

Support coding activities.

Participate in audits and inspection readiness activities.

Maintain professional relationships with:

Internal teams

External stakeholders

Project partners

Required Qualifications Education Eligible Qualifications: B.Pharm

M.Pharm

PharmD

BDS

BMS

MBBS Not Eligible: B.Sc

M.Sc Required Experience & Skills Minimum 1 year of experience handling Product Quality Complaint (PQC) cases exclusively.

Experience handling medical research-related safety cases.

Hands-on experience with:

Argus safety database

ARISg safety database

Strong understanding of

Pharmacovigilance regulations

Safety reporting requirements

Knowledge of

Clinical trial phases II–IV

Post-marketing safety

Proficiency in Microsoft Office applications.

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 The Organization Promotes: Career development

Technical training

Inclusive workplace culture

Global collaboration Equal Opportunity Statement Syneos Health is committed to building a diverse and inclusive workplace. The company provides equal employment opportunities and reasonable accommodations for qualified individuals with disabilities. Safety & PV Specialist I - PQC Company: Syneos Health Location: Gurgaon, India Job ID: 25107950 Employment Type: Full-Time Work Mode: Office-Based Experience Required: 2.5 – 4 Years Syneos Health Focuses On: Clinical development solutions

Medical affairs

Commercial insights

Patient-focused healthcare innovation Job Summary The Safety & Pharmacovigilance Specialist I – Medical Device & PQC is responsible for: End-to-end Individual Case Safety Report (ICSR) processing

Safety data management

Regulatory reporting support

Compliance with global pharmacovigilance regulations

Product Quality Complaint (PQC) case handling

Medical research-related safety case processing 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) and project-specific safety plans.

Triage ICSRs and evaluate

Completeness

Accuracy

Regulatory reportability

Enter case data into safety databases such as:

Argus

ARISg

Perform coding of

Adverse events

Medical history

Concomitant medications

Laboratory tests

Code using

MedDRA

Relevant medical dictionaries

Prepare accurate medical narrative summaries.

Identify missing or inconsistent information.

Follow up on queries until resolution.

Identify and manage duplicate ICSRs.

Perform quality review of ICSRs.

Regulatory Reporting & Compliance Support preparation and submission of expedited safety reports.

Ensure reporting activities comply with global regulatory requirements.

Validate and submit xEVMPD product records.

Perform MedDRA coding of indication terms.

Perform manual recoding of uncoded product and substance terms.

Support SPOR / IDMP activities.

Maintain safety tracking activities.

Ensure documentation submission to

Trial Master File (TMF)

Pharmacovigilance System Master File (PSMF)

Apply safety reporting regulatory intelligence.

Maintain compliance with

SOPs

Work Instructions (WIs)

GCP

ICH guidelines

GVP regulations

Global drug, biologic, and device regulations

Literature, Audit & Collaboration Perform literature screening and safety reviews.

Maintain drug dictionaries.

Support coding activities.

Participate in audits and inspection readiness activities.

Maintain professional relationships with:

Internal teams

External stakeholders

Project partners

Eligible Qualifications: B.Pharm

M.Pharm

PharmD

BDS

BMS

MBBS Not Eligible: B.Sc

M.Sc Required Experience & Skills Minimum 1 year of experience handling Product Quality Complaint (PQC) cases exclusively.

Experience handling medical research-related safety cases.

Hands-on experience with:

Argus safety database

ARISg safety database

Strong understanding of

Pharmacovigilance regulations

Safety reporting requirements

Knowledge of

Clinical trial phases II–IV

Post-marketing safety

Proficiency in Microsoft Office applications.

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 The Organization Promotes: Career development

Technical training

Inclusive workplace culture

Global collaboration Equal Chance Statement Syneos Health is committed to building a diverse and inclusive workplace. The company provides equal employment opportunities and reasonable accommodations for qualified individuals with disabilities.

📌 Safety & PV Specialist I - PQC (India)
🏢 The Pharma Daily - Powered by Vigisolvo
📍 India