ICON is hiring for the position of Pharmacovigilance Associate in Bangalore, India. The role focuses on pharmacovigilance and drug safety activities, including adverse event processing, safety data analysis, signal detection, regulatory reporting, database management, and compliance.

The position is available as Office or Home and is offered on a full-time basis.

Job Details

Position

Pharmacovigilance Associate

The Pharmacovigilance Associate will manage and oversee pharmacovigilance activities and take ownership of drug safety deliverables, including adverse event reporting, safety data analysis, regulatory documentation, and pharmacovigilance database management.

Responsibilities

• Lead the collection, evaluation, and processing of adverse event reports in accordance with regulatory guidelines and company policies.
• Conduct safety data analysis and interpretation to identify trends and potential safety signals.
• Prepare and submit periodic safety update reports (PSURs) and other regulatory documents.
• Collaborate with medical and clinical teams to assess the clinical relevance of adverse events.
• Contribute to risk management activities.
• Oversee the maintenance and integrity of pharmacovigilance databases.
• Ensure accurate documentation and compliance with data management standards.
• Provide training and mentorship to junior team members on pharmacovigilance processes and regulatory requirements.
• Participate in regulatory audits and inspections.
• Ensure readiness and compliance with pharmacovigilance requirements.

Eligibility & Qualifications

Candidates should have:

• A Bachelor’s degree in a relevant scientific discipline or healthcare-related field.
• Extensive experience in pharmacovigilance or drug safety.
• Strong understanding of relevant regulations and industry standards.
• Experience managing pharmacovigilance processes, including adverse event reporting and signal detection.
• Ability to work independently and manage multiple priorities in a fast-paced environment.
• Willingness to travel approximately 15%.

Required Skills

• Pharmacovigilance and drug safety
• Adverse event reporting
• Signal detection
• Safety data analysis and interpretation
• Regulatory reporting
• PSUR preparation and submission
• Pharmacovigilance database management
• Data management
• Risk management
• Regulatory compliance
• Analytical and critical thinking
• Cross-functional collaboration
• Communication and interpersonal skills
• Microsoft Office Suite

Application Details

Application Link