Pharmacovigilance Services Associate Manager

Role & Responsibilities
• Manage affiliate safety mailboxes and reconciliation of safety reports as per defined processes
• Perform written follow-ups for both serious and non-serious ICSRs
• Oversee case identification, data entry, MedDRA coding, processing, submission, and follow-ups in safety databases
• Ensure ICSR handling complies with global pharmacovigilance regulations and client SOPs
• Review and monitor team performance, quality metrics, and timelines
• Manage medium-sized PV teams and provide guidance and mentorship
• Drive problem-solving for moderately complex PV operational challenges
• Implement process improvements and new workflow solutions
• Ensure compliance with client and regulatory requirements
• Support rotational shift operations as required

Qualifications & Experience
• Bachelor of Pharmacy
• 10–14 years of experience in Pharmacovigilance / Drug Safety Operations
• Strong understanding of global PV regulations and ICSR lifecycle
• Experience managing teams and safety workflows

Skills
• Pharmacovigilance operations & ICSR lifecycle management
• MedDRA coding and safety database handling
• Affiliate reconciliation and follow-up management
• Global PV regulations & compliance
• Team leadership and performance management
• Process improvement & root cause analysis
• Strong analytical and decision-making skills
• Effective communication and stakeholder management

About the Company
• Accenture is a global professional services company delivering digital, cloud, security, consulting, technology, and operations solutions to life sciences and healthcare organizations across 120+ countries