Assistant Manager, Pharmacovigilance Epidemiology & Risk Management
Risk Management & Compliance
93+ Applicants
Posted: 1 month ago
10-15 years
Noida
work from office
Posted: 1 month ago
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Applicants: 93+
Job Description
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Job Description
- To write/ review QA documents such as SDEA s, Working Instructions, SOPs, Working Procedures, templates, project metafiles etc. for PharmaLex Pharmacovigilance projects.
- To organize and perform training of the above-mentioned documents.
- Identification (Classification of references) of safety- relevant publications in the scientific literature. Provision of scientific input in the course of literature surveillance service.
- Screening scientific literature by using the internal search mechanism and/or by making use of external tools and providers.
- Medical assessment of literature reports into the safety database.
- Act as main contact for client/project management.
- The employee agrees to take over primary listed tasks and responsibilities in other service lines and additional reasonable tasks that align with their abilities, qualification and training, if required.
- Responsible for quality management, workload management, compliance management and document management for the assigned PV projects.
- Acts as line manager of assigned staff.
- Manages project coordination and resource allocation within the projects.
- Train and mentor PV department staff, as needed.
- Ensures monthly invoices are generated and shared for all PV clients on regular/monthly basis.
- Responsible for recruitment of new staff in PV Department.
- Is involved in objective setting and annual appraisals of staff.
- Ensures training compliance by PV staff at all times.
- Represents PV department during for-cause/maintenance client audits or regulatory authority inspections.
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Education:
- University degree in Life Science
Experience:
- Minimum 10 years of experience and profound knowledge in the field of pharmacovigilance
Skills:
- Good communication skills (written and verbally); capability to point out issues and provide potential options for solution in the area of expertise.
Skills
LiteratureComplianceProject ManagementProject CoordinationCompliance ManagementResource AllocationDocument ManagementPharmacovigilanceComplianceRegulatoryRisk ManagementIf an employer asks you to pay any kind of fee, please notify us immediately. Jobaaj does not charge any fee from the applicants and we do not allow other companies also to do so.
Important dates & deadlines?
Application Deadline
27 Apr 26, 03:52 PM IST
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