Senior Pharmacovigilance Specialist

Propharma Group India; Bengaluru, Hyderabad; Hybrid; INR 8,00,000 - 12,00,000; Full time

Job summary

A leading pharmaceuticals company is seeking a skilled Pharmacovigilance Specialist in Bangalore / Hyderabad. The ideal candidate will have at least 4 years of experience in Individual Case Safety Reports (ICSR) processing, a strong understanding of global pharmacovigilance regulations, and the ability to work with cross-functional teams. The role entails case processing and ensuring compliance with relevant regulations, along with preparation of safety reports.

Qualifications

• Minimum 4 years of hands-on experience in PV ICSR processing.
• Strong understanding of global PV regulations and ICH-GCP guidelines.
• Good communication and documentation skills.

Responsibilities

• Perform case intake, triage, data entry, quality review, and submission of ICSRs.
• Ensure timely reporting of adverse events to regulatory authorities.
• Prepare periodic safety update reports (PSURs) as required.

Skills

Case processing

Adverse event evaluation

Attention to detail

Analytical skills

Communication

Education

Bachelor's or Master's degree in Pharmacy or Life Sciences

Tools

PV databases (e.g., Argus, ArisG)

Job description

Job Title: Pharmacovigilance Specialist
Location: Bangalore / Hyderabad
Experience: Minimum 4 Years in PV ICSR
Job Summary

We are seeking a skilled and detail-oriented Pharmacovigilance (PV) Specialist with hands-on experience in Individual Case Safety Reports (ICSR). The ideal candidate will be responsible for end-to-end case processing and ensuring compliance with global PV regulations and internal SOPs.

Key Responsibilities:

• Perform case intake, triage, data entry, quality review, and submission of ICSRs.
  
• Evaluate and code adverse event reports using MedDRA and WHO-DD coding.
  
• Ensure timely reporting of adverse events to regulatory authorities and clients.
  
• Maintain compliance with pharmacovigilance regulations (e.g., FDA, EMA, CDSCO).
  
• Collaborate with cross-functional teams to ensure accurate and complete safety data.
  
• Contribute to audit and inspection readiness.
  
• Prepare periodic safety update reports (PSURs) and other regulatory documents when required.
  

Qualifications:

• Bachelors or Masters degree in Pharmacy, Life Sciences, or related field.
  
• Minimum 4 years of hands-on experience in PV ICSR processing.
  
• Strong understanding of global PV regulations and ICH-GCP guidelines.
  
• Familiarity with PV databases (e.g., Argus, ArisG) is an advantage.
  
• Excellent attention to detail and strong analytical skills.
  
• Good communication and documentation skills.
  

Preferred Attributes:

• Certification in Pharmacovigilance will be an added advantage.
  
• Ability to work independently and as part of a team.
  
• Willingness to work in shifts if required (based on client/region).