Executive Recruitment company Monroe Consulting Group is recruiting on behalf of a Healthcare Technology company that offers digital application/mobile app exclusive for doctors that will enable them to have access to features such as forums for knowledge sharing, trainings & webinars for CME, virtual conventions, categorised channels.
The Pharmacovigilance Lead will manage the day-to-day operations within the PV department and liaise with the team and management to ensure effective functioning of the department and address any concerns or issues. This role will be primarily responsible for the quality and compliance of all PV deliverables and be involved in training, business development, audits/inspections, client relationship management and line management.
Key Job Responsibilities:
- Ensure effective functioning of all PV projects in compliance with client agreement, contract; and local and global regulatory guidelines.
- Responsible for quality management, workload management, compliance management and document management across all PV projects.
- Manage project and resource allocation within the PV department.
- Validates and implements upgrades to the safety database, in conjunction with IT department and the vendor.
- Train and mentor PV department staff, as needed and ensure compliance.
- Monitor workload of department.
Key Job Qualifications:
- MD with postgraduation training
- 6+ years' experience in the CRO or pharmaceutical industry including 4 years or more pharmacovigilance experience.
- Awareness of global regulatory environment.
- Awareness of pharmacovigilance environment.
- Project Management (Clinical and Post- marketing environments)
- Line Management
- Performance review and appraisals for staff
- Exposure to Aggregate Reports (DSUR/PSUR)
- Knowledge of QPPV tasks like RMP, SDEA, SPC updates, PSMF etc.
- Devising and establishing processes and procedures.
- Experience with ARGUS or ARISg is plus
