Position : Team Lead

These team members will be recruited at FHS PV unit for managing a team of Data Entry, Quality Review of ICSRs and Aggregate Reports. All these employees would be having expertise and experience in managing teams doing PV activities with reputed PV firms.

Experience : 3-5 years in managing PV teams

Educational background: B. Pharm; M. Pharm, BHMS/ BAMS/ BDS

General Technical responsibilities
Team leads will become members of the safety team, which is responsible for processing of ICSRs. They will especially focus on defining and integrating user/stakeholder requirements and safety risk management.
They will be given a number of different responsibilities and experience a variety of tasks, working with both internal and external stakeholders. The job will enhance their professional and personal development, providing them with an opportunity to develop skills within specialist expertise and project management.
To contribute to the collection, medical evaluation and reporting (to the authorities) concerning adverse events/technical complaints from clinical use of Client’s preparations and products whether the product is in clinical development or Primary driver of process optimization of the operational case handling
Contribute to the build-up of a strong team, which can work professionally in the operational handling of adverse events in close collaboration with affiliates and other partners.
Maintain a network of safety contacts within safety operations and affiliates. Conduct performance management, individual development plans, job descriptions and performance evaluation.
Ensure continuous development of employees, training/coaching in pharmacovigilance and in departmental functions.
To participate in the development and maintenance of departmental and functional procedures which have to ensure the observance of internal and external requirements for the management of safety information
Monitor and ensure that KPIs for evaluation and reporting of adverse events are maintained.
Measure and present internal and regulatory compliance.
Responsible for providing inputs for updates of SOPs.
Provide input to safety data exchange agreements and pharmacovigilance system description documents regarding the post marketing surveillance process.
Conduct safety trainings for new pharmacovigilance staff and other company units.
Establish and maintain a thorough understanding of safety requirements of the project protocol, and safety reporting workflow, set up and maintain project materials such as project files, forms, templates, databases and workflow.
Establish and maintain effective project communications by representing department at interdepartmental project team meetings to understand and adhere to specific safety reporting requirement.
The tasks demand self-dependence and competence in making decisions, as well as flexibility, a good comprehensive view and a many-functioned, often international, co-operation.