PharSafer® is recruiting for the position of Pharmacovigilance Associate in India for its global Pharmacovigilance team. Candidates with a Bachelor’s or Master’s degree in Pharmacy and 2–3 years of Pharmacovigilance experience can apply.
The role involves Individual Case Safety Report (ICSR) processing, safety report quality review, MedDRA coding, case follow-up, Drug Safety mailbox monitoring, and pharmacovigilance compliance activities.
This is a remote working opportunity within India, offering exposure to international pharmaceutical, biotechnology, and life sciences clients.
Job Details
| Particulars | Details |
|---|---|
| Company | PharSafer® |
| Job Title | Pharmacovigilance Associate |
| Job Location | India |
| Work Mode | Remote |
| Experience | 2–3 Years |
| Qualification | B.Pharm / M.Pharm |
| Department | Pharmacovigilance |
| Industry | Pharmaceutical / Life Sciences |
| Employment Type | Full-time |
About PharSafer®
PharSafer® is a specialist Pharmacovigilance and Medical Services Contract Research Organisation (CRO), headquartered in the UK with offices in India.
The company provides pharmacovigilance, medical, regulatory, and compliance services to pharmaceutical, biotechnology, advanced therapy, medical device, and cosmetic companies throughout the product lifecycle.
Key Responsibilities
1. ICSR Processing and Quality Review
- Perform safety report data entry and quality review in assigned safety databases.
- Verify case information against source documents for accuracy, completeness, and consistency.
- Identify missing or unclear information and raise queries.
- Undertake local safety report processing where required.
- Complete assigned activities within agreed timelines.
2. MedDRA Coding and Case Maintenance
- Perform MedDRA coding assessments according to approved conventions and project requirements.
- Refer coding queries for clarification or specialist review.
- Complete authorised case corrections and logical deletions.
- Maintain accurate and traceable records.
3. Safety Report Follow-up
- Identify information requiring follow-up.
- Prepare follow-up requests through approved channels.
- Document follow-up attempts, responses, and outstanding information.
- Update safety reports with newly received information.
- Escalate unresolved queries and delays.
4. Drug Safety Mailbox and EudraVigilance
- Monitor assigned Drug Safety mailboxes.
- Route incoming safety information and queries appropriately.
- Track outstanding items and escalate urgent matters.
- Download safety reports from EudraVigilance where assigned and authorised.
- Maintain report retrieval records.
5. Quality and Compliance
- Follow company procedures and client-specific instructions.
- Maintain accurate, complete, and traceable records.
- Protect confidential patient, reporter, and client information.
- Report quality concerns, processing errors, and system issues.
- Complete required training and implement feedback.
Eligibility and Qualifications
Candidates must meet the following essential requirements:
- Bachelor’s or Master’s degree in Pharmacy.
- 2–3 years of experience in Pharmacovigilance.
- Practical knowledge of safety report processing.
- Working knowledge of MedDRA coding.
- Existing right to work in India.
Desirable Experience
- Understanding of clinical development and post-marketing drug safety.
- Exposure to different pharmacovigilance systems and safety databases.
- Experience managing Drug Safety mailboxes.
- Experience with safety report follow-up.
- Experience retrieving safety reports from EudraVigilance.
Required Skills
- Individual Case Safety Report (ICSR) processing.
- Pharmacovigilance case quality review.
- MedDRA coding.
- Safety report follow-up and case maintenance.
- Drug Safety mailbox management.
- EudraVigilance report retrieval.
- Pharmacovigilance documentation and compliance.
- Strong written and verbal communication.
- Attention to detail and organisational skills.
- Ability to prioritise tasks and meet timelines.
- Ability to work independently and collaboratively in a remote team.
Benefits and Career Development
PharSafer offers:
- Structured training and ongoing professional development.
- Career development opportunities within Pharmacovigilance.
- Remote working within India.
- Flexible working arrangements.
- Company laptop and required software.
- Opportunities to work with experienced Pharmacovigilance Physicians and Drug Safety professionals.
- Exposure to international projects and a diverse client portfolio.
