Pharmacovigilance Associate

Pharsafer Associates; New Delhi; Remote; INR 600,000 - 900,000; Full time

Job summary

Pharsafer Associates is seeking a Pharmacovigilance Associate in India to support processing and quality review of Individual Case Safety Reports as part of a global PV team. The role focuses on accurate data processing, coding, follow-up, and safety-report administration across international clients.

You will work remotely with Pharmacovigilance colleagues and physicians, applying approved procedures and client requirements. A pharmacy degree and 2–3 years PV experience are essential.

Qualifications

• Bachelor’s or Master’s degree in Pharmacy.
• 2–3 years of Pharmacovigilance experience.
• Knowledge of safety-report processing and accuracy.
• Proficiency in MedDRA coding and conventions.
• Excellent written and verbal communication.
• Strong attention to detail and ability to meet timelines.
• Ability to work remotely within a cross-functional team.
• Existing right to work in India.

Responsibilities

• Process and quality-review safety reports within assigned databases.
• Perform MedDRA coding and case maintenance with accuracy.
• Handle safety-report follow-up and information requests.
• Monitor safety mailboxes and retrieve reports from systems.
• Maintain compliant, traceable records and escalate issues.

Skills

Communication skills

Attention to detail

Organisational skills

Proactive attitude

Independent work

Remote collaboration

Education

Bachelor's degree in Pharmacy

Master's degree in Pharmacy

Tools

MedDRA

EudraVigilance

Job description

Job Summary

Pharmacovigilance Associate within our growing global Pharmacovigilance team in India. If you hold a bachelor's or master's degree in Pharmacy and have 2-3 years of experience in Pharmacovigilance, this is an opportunity to build on your skills whilst working with international pharmaceutical, biotechnology and life sciences clients. Working remotely as part of our collaborative global team, you will support accurate and timely safety-report processing, contributing to programmes that help protect patients worldwide.

The Role

As a Pharmacovigilance Associate, you will support the processing and quality review of Individual Case Safety Reports (ICSRs), alongside coding, follow-up and safety-report administration. You will work with Pharmacovigilance colleagues, Physicians and project teams, following approved procedures and client requirements. Your assigned activities will reflect your training, experience and project needs, with support and specialist review available where required.

Key Responsibilities

Safety Report Processing and Quality Review

• Perform data entry and/or quality review of safety reports within assigned safety databases.
• Check case information against source documents for accuracy, completeness and consistency.
• Identify missing or unclear information and raise queries with the appropriate colleagues.
• Undertake local processing of safety reports where required.
• Complete assigned activities within agreed timelines and highlight issues that may affect delivery.

MedDRA Coding and Case Maintenance

• Perform MedDRA coding assessments in accordance with approved conventions and project requirements.
• Refer coding queries for clarification or specialist review where needed.
• Complete authorised case corrections and logical deletions, maintaining accurate and traceable records.

Safety Report Follow-up

• Identify information requiring follow-up and prepare requests through approved channels.
• Document follow-up attempts, responses and outstanding information.
• Update safety reports with information received and escalated unresolved queries or delays.

Drug Safety Mailbox and Report Retrieval

• Monitor assigned Drug Safety mailboxes and route incoming information and queries appropriately.
• Track items requiring action and escalation urgent or outstanding matters.
• Download safety reports from EudraVigilance where assigned and authorised.
• Maintain records supporting accurate report retrieval and onward processing.

Quality and Compliance

• Follow Company procedures, client-specific instructions and applicable requirements.
• Maintain accurate, complete and traceable records.
• Protect confidential patient, reporter and client information.
• Raise quality concerns, processing errors and system issues promptly.
• Complete required training and apply feedback to improve accuracy and consistency.

Qualifications & Skills

Essential

• A bachelor's or master's degree in Pharmacy.
• 2-3 years experience in Pharmacovigilance.
• Practical knowledge of safety-report processing, including the importance of accuracy, completeness and timely handling.
• Working knowledge of MedDRA coding and the ability to apply approved coding conventions.
• Excellent written and verbal communication skills.
• Strong attention to detail and a conscientious, professional approach.
• Strong organisational skills, with the ability to prioritise work and meet agreed timelines.
• A proactive attitude, with the ability to work independently and recognise when clarification or escalation is needed.
• Ability to work collaboratively within a remote, cross-functional team.
• Existing right to work in India.

Desirable

• A good understanding of clinical development and post-marketing drug safety.
• Exposure to different pharmacovigilance systems, processes and safety databases.
• Experience managing Drug Safety mailboxes, undertaking safety-report follow-up or retrieving reports from EudraVigilance.

Disclaimer: This job posting and Location has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.