Pharmacovigilance Specialist

Role Overview

As a Pharmacovigilance Specialist at Pharmaleaf, you will be responsible for evaluating safety data across clinical trials and post-marketing programs. You will ensure full compliance with FDA, EMA, ICH, and global regulatory authority guidelines by processing adverse event reports, generating aggregate safety reports, and contributing to signal detection activities.

Key Challenges & Impact

You will work closely with cross-functional clinical safety teams, medical reviewers, and regulatory leaders to identify emergent safety signals, update risk management plans (RMPs), and ensure client trial programs maintain audit readiness.

Key Responsibilities

• Process, triage, and evaluate Individual Case Safety Reports (ICSRs) from clinical trials and spontaneous post-marketing sources.
• Apply MedDRA medical coding to adverse events, medical history, and concomitant medications.
• Draft and contribute to aggregate safety reports including PSURs, PBRERs, DSURs, and Periodic Safety Update Reports.
• Perform initial safety signal evaluation and trend analysis using Argus Safety / ARISg systems.
• Liaise with health authorities (FDA, EMA, MHRA) regarding safety queries and expedited reporting validation.
• Participate in internal compliance audits and client mock inspections to maintain continuous audit readiness.

Qualifications & Requirements

• Bachelor's or Master's degree in Pharmacy (B.Pharm/M.Pharm), Pharmacology, Life Sciences, or PharmD.
• 3+ years of direct pharmacovigilance and drug safety processing experience within a CRO or pharma sponsor environment.
• Expert proficiency in global safety databases (Oracle Argus Safety or ARISg) and MedDRA/WHO-Drug dictionaries.
• In-depth working knowledge of FDA 21 CFR 314.80, EMA GVP Modules, and ICH E2A-E2F guidelines.
• Strong analytical mindset with high attention to medical accuracy and regulatory deadlines.