Welcome Back

Google icon Sign in with Google
OR
I agree to abide by Pharmadaily Terms of Service and its Privacy Policy

Create Account

Google icon Sign up with Google
OR
By signing up, you agree to our Terms of Service and Privacy Policy
Instagram
youtube
Facebook

Safety & Pharmacovigilance Specialist I – Pharmacovigilance

Syneos Health
Syneos Health
0-2 years
preferred by company
Pune, India
2 May 18, 2026
Job Description
Job Type: Full Time Education: M.Pharm/B.Pharm or M.Sc. Skills: ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment

Safety & Pharmacovigilance Specialist I – Pharmacovigilance / Drug Safety Jobs in Pune | Syneos Health

Location: Pune, India
Company: Syneos Health
Job Type: Full-Time
Department: Clinical Solutions / Pharmacovigilance
Experience Required: Freshers to 2 years of relevant experience
Job ID: 25107956


About the Company

Syneos Health is a globally recognized biopharmaceutical solutions organization that supports drug development, clinical research, and commercialization for leading healthcare innovators worldwide. With extensive experience across FDA-approved drugs, EMA-authorized products, and global clinical trials, the company continues to drive innovation in patient safety and healthcare advancement.

This opportunity is ideal for candidates seeking to build a career in pharmacovigilance, drug safety, case processing, medical coding, and regulatory safety operations within a highly professional global work environment.


Job Overview

We are hiring a Safety & Pharmacovigilance Specialist I for a leading global clinical research and life sciences organization in Pune. This role is ideal for fresh graduates and early-career professionals interested in pharmacovigilance operations, individual case safety report (ICSR) processing, MedDRA coding, literature surveillance, safety database management, and regulatory compliance.

The selected candidate will support global drug safety activities by processing adverse event reports, maintaining pharmacovigilance documentation, ensuring regulatory compliance, and contributing to quality-focused safety operations.


Key Responsibilities

ICSR Processing & Case Management

  • Receive, triage, and process Individual Case Safety Reports (ICSRs) in accordance with SOPs and pharmacovigilance guidelines.
  • Review case data for completeness, medical accuracy, consistency, and regulatory reporting requirements.
  • Enter safety case information into pharmacovigilance tracking systems and validated safety databases.
  • Identify missing information, raise queries, and follow up until case closure.

Medical Coding & Safety Data Management

  • Perform MedDRA coding for adverse events, indications, and medical terms.
  • Code concomitant medications, medical history, laboratory findings, and treatment-related information.
  • Support maintenance of drug dictionaries and pharmacovigilance coding systems.
  • Conduct manual recoding of unresolved product or substance terms from safety reports.

Narrative Writing & Reporting

  • Prepare clear and medically accurate case narratives for safety submissions.
  • Assist in expedited safety reporting according to global regulatory timelines.
  • Ensure timely and accurate safety report submissions.

Literature Review & Signal Support

  • Perform literature screening for potential adverse event reports.
  • Review published safety-related medical literature for reportable cases.
  • Support safety surveillance activities and regulatory intelligence implementation.

Regulatory Compliance & Safety Documentation

  • Support xEVMPD validation and product record submission activities.
  • Contribute to SPOR / IDMP-related pharmacovigilance processes.
  • Maintain pharmacovigilance documentation in Trial Master File (TMF) and Pharmacovigilance System Master File (PSMF).
  • Ensure compliance with GVP, ICH, GCP, SOPs, Work Instructions, and global drug safety regulations.

Quality Assurance & Operational Support

  • Perform quality review of ICSRs and pharmacovigilance documentation.
  • Detect and manage duplicate safety cases.
  • Participate in audits, inspections, and quality improvement initiatives.
  • Collaborate with internal project teams, sponsors, and pharmacovigilance stakeholders.

Required Qualifications

  • Bachelor’s degree in Pharmacy, Life Sciences, Biotechnology, Nursing, Medicine, Clinical Research, or related healthcare discipline
  • Strong understanding of pharmacovigilance principles and drug safety workflows
  • Knowledge of ICSR processing, MedDRA coding, adverse event reporting, and regulatory compliance
  • Familiarity with global pharmacovigilance regulations preferred
  • Good written communication and medical documentation skills
  • Strong analytical and attention-to-detail mindset
  • Ability to work in a structured, deadline-driven environment