Soterius·1 month ago
1 month ago
Assistant Manager - Compliance Management
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About this role
Role Overview -
Accountable for the quality management system, compliance, and inspection readiness of a large OTC/consumer healthcare pharmacovigilance program handling large volume cases per year. Report to the Director Safety and operate independently of the delivery line to provide objective quality oversight across all functions.
Key Responsibilities -
- Own and maintain the quality management system across the entire PV operation.
- Lead deviation and CAPA management, including root cause analysis and effectiveness checks.
- Drive ongoing audit and inspection readiness and lead the quality response during regulatory inspections and client audits.
- Perform compliance monitoring against regulatory timelines and internal SLAs, identifying and escalating risks.
- Own SOP and controlled document management, including periodic review and version control.
- Conduct quality trend analysis across case processing, aggregate reports, literature, and affiliate functions, and drive corrective action.
- Maintain a dotted-line relationship with the client quality contact and support client quality governance.
- Deliver quality metrics and KPI/SLA compliance reporting to the Director Safety and client.
Qualification - Degree in Pharmacy, Medicine, Pharm D, BHMS, BDS or equivalent
Key Skills - PV administration and coordination | KPI, SLA and metrics reporting | MIS reporting | compliance trackers | Document management | Scheduling and meeting coordination | Client and internal team coordination | Safety database operational support
We are an equal opportunity employer committed to fostering a diverse, inclusive, and respectful workplace. We welcome applications from all qualified candidates and do not discriminate on the basis of race, colour, religion, gender, gender identity or expression, sexual orientation, age, disability, marital status, or any other characteristic protected by applicable law. Employment decisions are based on qualifications, skills, experience, and business needs.
Company
Soterius
Mumbai, India
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