Pharmacovigilance Associate
Pharsafer Associates · Delhi · onsite · Posted 2d ago
Undisclosed2–3 yrsfulltimeSourced from
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About this role
Job Summary
The Role
Key Responsibilities
Safety Report Processing and Quality Review
MedDRA Coding and Case Maintenance
Safety Report Follow-up
Drug Safety Mailbox and Report Retrieval
Quality and Compliance
Qualifications & Skills
Essential
Desirable
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.
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 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.
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.
Sourced from naukri
Skills
pharmacovigilanceCROmedical servicesDrug safetyMedDRApatient safetyclinical developmentBiotechnologyCosmeticCommunication SkillsmaintenanceAdministrationcomplianceData EntrymarketingPharmaceuticalLife Sciences