About Unilever
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We Are Looking To Hire a Manager, Global Market Vigilance (GMV) In Our Global Regulatory Affairs (GRA), Beauty & Wellbeing Business Group Based In India (Mumbai / Bangalore / Gurgaon)
Job Summary: This is a critical role responsible for managing adverse event complaint activities and processes of various products marketed by Unilever globally, both in-house and using external vendors. The successful candidate will also play a proactive role in the strategic planning and implementation of harmonized Market Vigilance procedures and systems worldwide.
The Key Responsibilities Include
• Engage external/ internal partners e.g. Call Center/Customer Experience Center (CEC) in the timely triage of potential adverse event complaints
• Screen and prioritize potential serious adverse event complaints (coming for our cosmetic, VMS, OTC, Med Device products) for case processing, and flagging to all relevant internal stakeholders
• Work with CEC to gather additional case details via follow-ups with consumers in an expeditious manner
• Assess AE trends, label and internal company data to determine expectedness of the AE/SAE cases
• Ensure quality reviews, causality assessments and narrative summaries are completed (in-house or by a vendor) in a timely manner
• Review and make sure AE and SAE cases requiring reporting to regulatory agencies (globally) are submitted in the mandated timeframe using proper forms (MedWatch, CIOMS) and preferred methods (online safety portals, E2B gateway)
• Oversee implementation of harmonized signal/trend reports and KPIs across various brands and business groups
• Create a records retention and archival process for all relevant documentation
• Author relevant Standards, SOPs and Work Instructions as needed
• Provide training and presentation to CEC and various other functions as necessary to emphasize Market Vigilance requirements
• Conduct internal audits as well as setup 3 rd party audits of company processes as well as vendors to assure “inspection readiness”
• Work with relevant stakeholders (CEC, Pre-market Safety, RA, QA, R&D, Legal etc.) to enhance interactions and play an active part in driving overall regulatory compliance
Job Requirements
• MBBS or BDS with 10+ years’ expertise in Pharmacovigilance/Post-Market Safety
• Hands-on global experience in Consumer Healthcare as well as Beauty & Personal Care industries (OTC and Rx Drugs, Cosmetics, Dietary Supplements and Medical Devices)
• Robust causality & medical assessment experience using MedDRA coding
• Proficient in authoring medical narrative summaries and expert safety reports to support regulatory enquiries and submissions
• Good understanding of global adverse event regulations as well as regulatory compliance requirements and timelines
• Experience with people management and overseeing outsourced operational activities
Key Attributes Required
• Self-motivated with a drive to succeed
• Accountable leader who engages and mentors colleagues
• Strong written and verbal communication
• Ability to demonstrate agility and work effectively in a team environment
Direction/Responsibility
• Reports to Head, Global Market Vigilance
• Operates independently with minimal supervision
