Pharmacovigilance Associate - India

Pharsafer Associates Limited; India; Remote; INR 500,000 - 700,000; Full time

Benefits offered by this job

Remote working within India

Structured training & development

Laptop provided

Job summary

PharSafer Associates Limited in India is seeking a Pharmacovigilance Associate to support processing and quality review of Individual Case Safety Reports (ICSRs), MedDRA coding, and safety follow-up. This remote role requires a Pharmacy degree and 2–3 years PV experience, with a focus on accuracy and timely handling.

You will work with international clients, ensuring compliance with procedures and maintaining documentation. A flexible, remote setup within India is provided.

Qualifications

• Bachelor’s or Master’s degree in Pharmacy.
• 2–3 years’ experience in Pharmacovigilance.
• Knowledge of safety-report processing and MedDRA coding is preferred.
• Excellent written and verbal communication skills.
• Ability to work independently in a remote, cross-functional team.

Responsibilities

• Data entry and quality review of safety reports in safety databases.
• MedDRA coding assessments and follow-up on coding queries.
• Identify missing information and raise queries with colleagues.
• Monitor drug safety mailboxes and retrieve reports as needed.
• Maintain accurate, complete and traceable safety records.

Skills

Pharmacovigilance experience

Excellent communication

Attention to detail

Organisational skills

Remote teamwork

Education

Bachelor's degree in Pharmacy

Master's degree in Pharmacy

Job description

About The Job - Pharmacovigilance Associate

We are recruiting for the role of 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’ 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’ll support accurate and timely safety-report processing, contributing to programmes that help protect patients worldwide.

About PharSafer®

PharSafer® is a specialist Pharmacovigilance and Medical Services Contract Research Organisation (CRO), headquartered in the UK with offices in India. We support pharmaceutical, biotechnology, advanced therapy, medical device and cosmetic companies throughout the product lifecycle, delivering high-quality pharmacovigilance, medical, regulatory and compliance services.

Patient safety is a commitment at PharSafer. Our people bring that commitment to their work through accuracy, collaboration and a first-class service for our clients.

The Role

As a Pharmacovigilance Associate, you’ll support the processing and quality review of Individual Case Safety Reports (ICSRs), alongside coding, follow-up and safety-report administration.

You’ll 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 elevate 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 elevate 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:

• 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.
• 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.

Why Join PharSafer?

Join a specialist global Pharmacovigilance organisation where patient safety, quality and collaboration guide our work.

We offer:

• Structured training and ongoing professional development.
• Opportunities to develop your career within Pharmacovigilance.
• Remote working within India.
• Flexible working arrangements.
• A company laptop and the required software.
• The opportunity to work alongside experienced Pharmacovigilance Physicians and Drug Safety professionals on international projects across a diverse client portfolio.