Local Safety Officer

🔥 4 minutes ago

🇮🇳 India – Remote

⏰ Full Time

🟢 Junior

🟡 Mid-level

👻 Ghost score 10%

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ProductLife Group

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

💼 Consulting

🏥 Healthcare

💊 Pharmaceuticals

💰 GROWTH EQUITY VC on 2024-04

Consulting • Healthcare • Pharmaceuticals

ProductLife Group is a global life‑sciences consulting and outsourcing firm that pairs deep human expertise with intelligent automation to help bring therapies and health products from development to patient access. The company provides end-to-end solutions across product development (pre-clinical to approval), regulatory affairs, CMC & quality, clinical development, engineering and facility construction, market & patient access, safety and compliance, and digital & AI-enabled innovation. ProductLife Group serves biopharma, medtech and consumer health clients, operates a global network of offices covering 150+ countries, and highlights ~1,750 experts and ~10k+ submissions per year.

📋 Description

• Perform local safety case receipt, processing, and data entry • Track quality control (QC) and follow up on individual case safety reports (ICSRs) • Manage generic or client-specific email boxes • Register, triage, assign, and coordinate processing of vigilance cases • Send follow-up requests to local reporters • Respond to client and reporter queries • Conduct periodic reconciliations to confirm proper handling of vigilance reports for PLG clients • Support and contribute to local pharmacovigilance activities performed by the Local Safety/PV department • Participate in audits and inspections and support resulting action plans

🎯 Requirements

• Bachelor’s degree in science, Industrial Biology, or Chemistry Engineering • Minimum 2 years’ experience in pharmacovigilance working for service providers performing data entry and QC of cases • Previous experience working to deadlines • Client communications experience • Knowledge of EU PV regulations • Pharmaceutical background with strong understanding of GVP, GCP, FDA, and regulatory requirements related to drug safety • Deep knowledge of pharmacovigilance principles, adverse event reporting, and causality assessment • Database experience preferred • Process-oriented • Enjoys working with documentation • Good computer skills • Works well within a team • Knowledge of medical terminology • Organized • Flexible • Excellent communication skills in English

🏖️ Benefits

• Career growth opportunities • Opportunity to make a meaningful impact on global healthcare • Work with an innovative, forward-thinking global team • Purpose-driven work • Opportunity to contribute to the future of life sciences

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