Assistant Manager / Manager

Responsible for the execution of operational tasks and all aspects of technical delivery and project management in the field of Literature Screening.

Key Responsibilities :

• Responsible for quality management, workload management, compliance
• management and document management for the assigned PV projects.
• Manages project coordination and resource allocation within the projects.
• Train and mentor PV department staff, as needed.
• Ensure 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 for PV staff
• Represents PV department during for-cause / maintenance client audits or regulatory authority inspections.
• 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 during 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.

Qualifications

Skills Required

Project Coordination, Quality Management