Pharmacovigilance Associate (India)

Pharmacovigilance Associate (India)

28 Oct
|
PharSafer Associates
|
India

28 Oct

PharSafer Associates

India

Pharmacovigilance Associate – India

Build on your Pharmacovigilance experience with a specialist global drug safety team.

We are recruiting for the role of Pharmacovigilance Associate within our growing global Pharmacovigilance team in India.

This opportunity is suited to a Pharmacy graduate with 2-3 years experience in Pharmacovigilance who wants to develop their 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 MedDRA coding, follow-up and safety-report administration.

You'll work with Pharmacovigilance colleagues, Physicians and project teams, following approved procedures and client requirements. Assigned activities will reflect your training, experience and project needs, with specialist input and review 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 escalate 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 escalate 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.

What We're Looking For

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, qualified 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.

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.

Application Process

To apply, you must hold a bachelor's or master's degree in Pharmacy, have 2-3 years experience in Pharmacovigilance, and possess the right to work in India.

Please apply via the PharSafer website and submit:

- Your CV.
- A cover letter outlining your relevant experience and suitability for the role.
- Confirmation of your right to work in India.

Applications will only be considered when submitted via the PharSafer website. Direct applications or recruitment enquiries sent via LinkedIn, including messages to individual team members, will not receive a response.

The recruitment process will include multiple stages, including a technical skills assessment conducted by experienced Pharmacovigilance Managers/Directors.

Due to the volume of applications, we are unable to respond to every applicant. If you have not received a response within 10 working days of submitting your application, please assume your application has been unsuccessful on this occasion. Unfortunately, we are unable to provide individual feedback on applications.

We look forward to hearing from you!

📌 Pharmacovigilance Associate (India)
🏢 PharSafer Associates
📍 India

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