Regulatory Affairs, Pharmacovigilance / Quality Management Control Manager
Recruiting.com
full-time
Posted on:
Location Type: Remote
Location: Vietnam
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About the role
- Accountability for the execution of operational tasks in the Regulatory Strategy & Procedure Management Practice Area.
- Regulatory Affairs: Develop and maintain strong client relationships, participation in regulatory processes, preparation and review of documents, communication with clients and Health Authorities, planning and execution of client projects, general guidance of colleagues and clients regarding Regulatory Strategy, and regulatory intelligence.
- Pharmacovigilance: Set up and manage the local pharmacovigilance system, Local Literature Search, Local Individual Case Safety Report Collection, local signal detection, and ensure Pharmacovigilance training.
- Quality Management Control: Quality Management system maintenance, audits, training, oversight of labelling activities, management of returns and quality product complaints.
Requirements
- Education: University degree in Life Science.
- Proven experience, or demonstrable capability, in area of responsibility or similar field, advanced knowledge and insights required to perform complex tasks and strong practical knowledge of service area and how it impacts the related areas.
Benefits
- Benefit offerings outside the US may vary by country and will be aligned to local market practice. The eligibility and effective date may differ for some benefits and for team members covered under collective bargaining agreements.
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
Regulatory AffairsPharmacovigilanceQuality ManagementLocal Literature SearchIndividual Case Safety Report CollectionSignal DetectionQuality Management System MaintenanceAuditsTrainingLabelling Activities
Soft skills
Client Relationship ManagementCommunicationProject PlanningGuidanceCollaboration