Pharmacovigilance Services Specialist

Roles & Responsibilities
• Manage affiliate mailbox activities and reconciliation of safety reports as per defined processes
• Perform written follow-ups for both serious and non-serious adverse event cases
• Create and manage case identification, data entry, and MedDRA coding
• Process ICSRs including case submission and follow-up in safety databases
• Ensure compliance with global pharmacovigilance regulations and client guidelines
• Analyze and solve moderately complex pharmacovigilance and drug safety problems
• Contribute to new solutions by adapting existing methods and procedures
• Understand and align work with strategic direction set by senior management
• Interact with supervisors, peers, internal stakeholders, and client teams
• Manage small teams or work efforts when required
• Support pharmacovigilance operations across rotational shifts if needed

Qualification
• MBBS

Experience
• 7 to 11 years of experience in Pharmacovigilance / Drug Safety
• Strong exposure to ICSR processing and global safety surveillance
• Experience in affiliate case management preferred

Skills
• Pharmacovigilance and drug safety surveillance expertise
• Strong knowledge of ICSR processing and MedDRA coding
• Understanding of global regulatory requirements
• Analytical and problem-solving abilities
• Good written and verbal communication skills
• Ability to manage confidentiality of safety and client data
• Team handling and stakeholder coordination skills

About the Company
• Accenture is a global professional services leader Operates across digital, cloud, security, and life sciences domains Supports leading biopharma companies in R&D, regulatory, and pharmacovigilance services.