Pharmacovigilance Associate

Pharmacovigilance Associate:

Core Responsibilities:

• Case Processing: This involves receiving, reviewing, and processing reports of adverse events (side effects) associated with medications.
• Data Entry and Management: Accurately recording and maintaining safety information in databases.
• Medical Review: Assessing the information in adverse event reports to determine the seriousness and potential link to the medication.
• Follow-up: Contacting healthcare professionals or patients to obtain additional details about adverse events.
• Reporting: Preparing and submitting safety reports to regulatory authorities.
• Safety Monitoring: Staying updated on safety regulations and guidelines, and monitoring medical literature for potential safety signals.

Safety Reporting:

• Preparing regulatory reports: Generating and submitting Individual Case Safety Reports (ICSRs) and other required reports to regulatory authorities within specified timelines.
• Contributing to aggregate reports: Assisting in the preparation of periodic safety update reports (PSURs) and other aggregate reports that summarize safety data for a drug.

Safety Monitoring and Analysis:

• Literature review: Monitoring medical literature and regulatory websites for new safety information related to the company's products.
• Signal detection: Identifying potential safety signals by analyzing adverse event data and looking for patterns or trends.
• Risk management: Participating in the development and implementation of risk management plans to minimize the risks associated with drug use.

Compliance and Quality:

• Adhering to regulations: Ensuring compliance with all applicable pharmacovigilance regulations and guidelines (e.g., those from the FDA, EMA, etc.).
• Maintaining quality: Following company standard operating procedures (SOPs) and quality control measures to ensure the accuracy and completeness of safety data.

Qualifications:

• A degree in a life science field (e.g., pharmacy, nursing, biology) is often required.
• Experience in healthcare or pharmaceutical industry is a plus.

You can contact ( Call / Whatsapp ) HR Meena- 8438813362