Syneos Health is hiring for the position of Drug Safety Specialist I / II in Gurugram and Hyderabad. This is an excellent opportunity for pharmacovigilance professionals with experience in ICSR case processing, drug safety, narrative writing, MedDRA coding, clinical trial cases, and literature cases.

The Drug Safety Specialist role primarily involves end-to-end Individual Case Safety Report (ICSR) processing, including case triage, safety data entry, coding, narrative preparation, quality review, and ensuring cases are ready for regulatory submission.

Candidates with qualifications such as B.Pharm, M.Pharm, BHMS, BDS, and MDS can apply, subject to the education and experience requirements specified by Syneos Health.

Job Overview

*The salary range is an editorial estimate for structured-data purposes based on comparable pharmacovigilance roles in India and is not an officially disclosed Syneos Health salary.

Key Responsibilities

As a Drug Safety Specialist I / II at Syneos Health, selected candidates may be responsible for:

• Performing end-to-end ICSR case processing for spontaneous, clinical trial, and literature safety cases.
• Conducting accurate pharmacovigilance data entry as part of core case-processing activities.
• Performing initial case intake and triage of adverse event reports.
• Entering relevant patient, reporter, suspect drug, concomitant medication, and adverse event information into safety databases.
• Performing appropriate medical and safety terminology coding according to applicable processes.
• Preparing clear and medically relevant case narratives.
• Managing workflows covering triage, data entry, coding, narrative writing, and submission readiness.
• Ensuring ICSR cases comply with applicable global pharmacovigilance guidelines, SOPs, and regulatory requirements.
• Maintaining accuracy, consistency, completeness, and quality throughout the drug safety case-processing lifecycle.
• Performing quality control (QC) of processed safety cases depending on experience, training, and performance.

What Does a Drug Safety Specialist Do?

A Drug Safety Specialist works within pharmacovigilance to collect, process, evaluate, document, and support the reporting of adverse event information associated with pharmaceutical products.

For this Syneos Health position, the core responsibility is ICSR case processing. Candidates may work on adverse event reports received from spontaneous sources, clinical trials, and scientific or medical literature.

A typical workflow may include:

Case Receipt → Triage → Data Entry → Coding → Narrative Writing → Quality Check → Submission Readiness

This makes the position particularly relevant for professionals already working in pharmacovigilance case processing and drug safety operations.

Qualifications

According to the job posting, the following educational backgrounds are relevant:

UG Qualifications:

• B.Pharm / Bachelor of Pharmacy
• B.Pharm in Pharmaceutical Analysis and Quality Assurance
• BHMS – Bachelor of Homeopathic Medicine and Surgery
• BDS – Bachelor of Dental Surgery

PG Qualifications:

• M.Pharm / Master of Pharmacy
• MDS / Master of Dental Surgery

Candidates should check the official application page for the final eligibility criteria before applying.

Experience Required

Candidates with approximately 1–6 years of relevant experience are being considered for this Drug Safety Specialist I / II opening.

Relevant experience may include:

• Pharmacovigilance
• ICSR case processing
• Drug safety
• Safety data entry
• Case triage
• Narrative writing
• Literature case processing
• Clinical trial safety cases
• Case coding
• ICSR quality review

Applicants with direct hands-on end-to-end ICSR case processing experience are particularly aligned with the stated requirements.

Key Skills

Important skills for this Syneos Health pharmacovigilance job include:

ICSR Case Processing | Pharmacovigilance | Drug Safety | Narrative Writing | Case Triage | Safety Data Entry | Coding | Literature Cases | Clinical Trial Cases | Quality Control | Regulatory Compliance

Candidates should also have good attention to detail and an understanding of pharmacovigilance SOPs and global drug safety requirements.

Why Consider This Opportunity?

The Drug Safety Specialist I / II role provides professionals with an opportunity to build further expertise across multiple stages of the pharmacovigilance case lifecycle.

Potential professional benefits include:

• Exposure to end-to-end ICSR processing.
• Experience with spontaneous, clinical trial, and literature cases.
• Development of drug safety narrative-writing skills.
• Exposure to global pharmacovigilance processes and regulatory requirements.
• Experience in quality control and submission-readiness activities.
• Opportunity to develop a career within clinical research and pharmacovigilance operations.

Who Should Apply?

This opening is particularly suitable for candidates who have a relevant healthcare or pharmacy qualification and already possess practical experience in pharmacovigilance or ICSR case processing.

Candidates currently working as a Drug Safety Associate, Pharmacovigilance Associate, Safety Associate, ICSR Case Processor, PV Associate, or Drug Safety Specialist may find the responsibilities closely aligned with their existing experience.

How to Apply

Application Link