Data Officer – Pharmacovigilance
Job Code: 504
Location: India (Remote – UK Time Zone)
Employment Type: Permanent / Full-Time
Function: Safety & Vigilance | Pharmacovigilance
Work Model: Remote (UK business hours mandatory)
Job Overview
ProductLife Group (PLG) is hiring Data Officers – Pharmacovigilance to support global safety operations within its centralized Pharmacovigilance Hub. This role is ideal for experienced PV professionals with a strong background in ICSR processing, safety data entry, quality control, and regulatory compliance, who are comfortable working in the UK time zone and within a fast-paced, service-provider environment.
Key Responsibilities
Case Management & Safety Operations
Perform receipt, processing, data entry, QC tracking, and follow-up of Individual Case Safety Reports (ICSRs) in compliance with agreed timelines and client-specific requirements.
Manage generic and client-specific pharmacovigilance email inboxes, ensuring timely review and action.
Register, triage, assign, and coordinate vigilance cases across internal teams.
Follow-Up & Communication
Conduct follow-up with local reporters to obtain missing or additional safety information.
Respond professionally to queries from clients, reporters, and internal stakeholders.
Compliance & Reconciliation
Perform periodic reconciliations to confirm complete and accurate handling of all safety reports for PLG clients.
Support local and global pharmacovigilance activities as required by the PV department.
Participate in regulatory audits and inspections, including preparation and execution of corrective and preventive action (CAPA) plans.
Education & Qualifications
Bachelor’s or Master’s degree in Pharmacy, Medicine, Nursing, Life Sciences, or a related scientific discipline.
Equivalent pharmacovigilance experience may be considered in lieu of formal education, subject to country-specific requirements.
Experience Requirements
Minimum 2+ years of hands-on experience in Pharmacovigilance, preferably with a CRO or service provider.
Proven experience in ICSR data entry, case processing, and quality control activities.
Demonstrated ability to work under strict timelines and service-level agreements (SLAs).
Prior exposure to client communication and safety operations coordination is required.
Regulatory & Technical Knowledge
Strong understanding of UK and EU Pharmacovigilance regulations.
Solid pharmaceutical background with knowledge of GVP, GCP, FDA, and global drug safety requirements.
In-depth knowledge of pharmacovigilance principles, adverse event reporting, and causality assessment.
Hands-on experience with safety databases (e.g., Argus, ARISg, Veeva Vault Safety, or equivalent).
Key Skills & Competencies
Excellent organizational and interpersonal skills.
Strong time management with the ability to prioritize and manage multiple cases simultaneously.
High level of accountability, autonomy, and process orientation.
Strong attention to detail and quality-focused mindset.
Effective written and verbal communication skills, capable of explaining complex safety concepts clearly.
Ability to work collaboratively within global, cross-functional teams.
Flexible, adaptable, and able to perform efficiently in a dynamic, deadline-driven environment.
Why Join ProductLife Group
ProductLife Group is a global life sciences consulting and outsourcing partner supporting pharmaceutical, biotechnology, and medical device companies across the product lifecycle. PLG offers exposure to international clients, global regulatory environments, and long-term career growth in pharmacovigilance and regulatory science.
Apply Now
If you are a pharmacovigilance professional experienced in safety data processing and global PV regulations, apply today through thepharmadaily.com to join a growing international safety operations team.
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