Pharmacovigilance & Drug Safety Manager

Pharmacovigilance & Drug Safety Manager

Location-India (Hybrid / Remote / Office based as applicable)

Experience-512 years

Employment Type-Full Time

Role Overview

We are seeking an experienced Pharmacovigilance & Drug Safety Manager to oversee pharmacovigilance operations, safety surveillance, and regulatory compliance for pharmaceutical and healthcare clients across global markets.

The role requires strong expertise in drug safety monitoring, adverse event reporting, signal detection, and global pharmacovigilance regulations. The candidate will work closely with cross-functional teams including regulatory affairs, clinical development, medical affairs, and data analytics teams to ensure patient safety and regulatory compliance.

Key Responsibilities

Pharmacovigilance Operations

• Manage end-to-end pharmacovigilance processes including case intake, triage, data entry, and processing of Individual Case Safety Reports (ICSRs).
• Ensure timely submission of adverse event reports to regulatory authorities in compliance with global reporting timelines.
• Maintain quality standards in safety case processing and documentation.

Regulatory Compliance

• Ensure compliance with global pharmacovigilance regulations including FDA, EMA, MHRA, and ICH guidelines.
• Support preparation and submission of safety reports including:
• Periodic Safety Update Reports (PSUR / PBRER)
• Development Safety Update Reports (DSUR)
• Risk Management Plans (RMP)
• Support internal and regulatory audits and inspections.

Signal Detection & Safety Surveillance

• Conduct signal detection and safety surveillance activities using spontaneous reports, literature monitoring, and safety databases.
• Participate in signal evaluation, validation, and benefit-risk assessments.
• Assist in implementation of risk mitigation strategies.

Safety Systems & Data Analysis

• Work with pharmacovigilance safety databases such as Argus, ArisG, or similar systems.
• Perform coding using MedDRA and WHO Drug dictionaries.
• Support safety data analysis and trend monitoring.

Cross-Functional Collaboration

• Collaborate with regulatory affairs, clinical teams, quality assurance, and medical affairs.
• Provide pharmacovigilance guidance to internal teams and external stakeholders.
• Participate in safety governance meetings and regulatory discussions.

Process & Documentation

• Develop and maintain SOPs, work instructions, and safety documentation.
• Contribute to continuous improvement initiatives in pharmacovigilance processes.

Qualifications

• Bachelors or Masters degree in Pharmacy, Life Sciences, Medicine, or related field.
• 812 years of experience in pharmacovigilance, drug safety, or regulatory compliance.
• Strong knowledge of global pharmacovigilance regulations and reporting requirements.
• Hands-on experience with ICSR processing and safety databases.
• Familiarity with MedDRA coding and signal management processes.

Preferred Skills

• Experience in global CRO or consulting environments.
• Exposure to safety data analytics or AI tools in pharmacovigilance.
• Experience supporting regulatory inspections and audits.

Key Competencies

• Drug Safety Surveillance
• Global Pharmacovigilance Compliance
• Risk Management & Signal Detection
• Safety Data Analysis
• Stakeholder Collaboration
• Attention to Detail & Regulatory Accuracy