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

• Master s/Bachelor s degree in Pharmacy, Medicine, or a related field. Advanced degree preferred.
• Minimum of 6-9 years of experience in pharmacovigilance.
• Experience in handling pharmacovigilance activities for multiple countries.
• Excellent communication and interpersonal skills with special focus on Quality
• Ability to work effectively in a multicultural environment.
• we'll versed with pharmacovigilance regulations and guidelines and updated with the latest developments in regulatory guidelines
• Strong analytical and problem-solving skills.