Role & Responsibilities
• Lead and manage pharmacovigilance activities for drug safety
• Evaluate and process adverse event reports to ensure regulatory compliance
• Review and analyze safety data from clinical trials and post-marketing surveillance
• Prepare and submit pharmacovigilance reports, including PSURs and DSURs
• Provide safety expertise in interactions with regulatory authorities and health professionals
• Collaborate with cross-functional teams to ensure compliance with global safety regulations
• Mentor junior team members and contribute to continuous process improvements
Qualification
• MBBS/MD or equivalent medical degree
Experience
• 2-4 years of experience in Pharmacovigilance or Drug Safety
• Hands-on experience with safety databases and ICSR processing
Skills
• Strong understanding of global pharmacovigilance regulations
• Excellent communication and interpersonal skills
• Ability to analyze and interpret clinical data
• Detail-oriented with strong problem-solving skills
• Ability to work collaboratively in a team-oriented environment
About The Company
• APCERLS – A global provider of pharmacovigilance and regulatory affairs services, dedicated to supporting the healthcare industry with innovative safety solutions and regulatory compliance across various therapeutic areas.
Unlock refined AI insights.