As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client counter-parts.
Main Job Tasks and Responsibilities:
- Perform duplicate search, intake, and triage of the received source documents such as Spontaneous, Literature, Regulatory and clinical trials as per agreed timelines.
- Possess thorough knowledge of regulatory updates.
- Awareness and understanding of relevant GVP modules.
- Perform data entry which includes but not limited to causality, labeling and seriousness assessments, MedDRA coding for all the events, medical history, and laboratory findings, and drafting narratives. Complete the case processing activities within the stipulated time by prioritizing allocated cases in accordance with service level agreement and regulatory timelines and contribute to the management of daily workflow.
- Raise follow-up queries, as necessary, with appropriate documentation in the safety database or per applicable procedures within defined timelines.
- Ensure completeness and accuracy of the ICSR incorporating the medical review feedback comments and finalize the case as per service level agreements and regulatory timelines.
- Update the applicable project specific trackers in time.
- Review all follow-up information and identify relevant information and update the same in the safety database or per applicable procedures.
- Perform quality review as applicable, of triage and data entry steps which includes but not limited to causality, labeling and seriousness assessments, MedDRA coding for all the events, medical history, and laboratory findings, and narratives.
- Provide timely feedback to the associates as appropriate and document the errors as per stipulated procedures.
- Analyze the trend of errors, as applicable, in a particular project and assist the leads and managers to derive at remedial actions, as necessary.
- Support any additional quality gates as determined for the project.
- Participate in continuing awareness of company procedures and guidelines to maintain regulatory compliance.
- Actively participate in internal and client meetings.
- Ensure appropriate documentation to be 100 % audit and inspections ready.
- Complete all assigned training, both internal and client initiated, within specified due dates.
- Participate in process improvement initiatives to maintain the Quality and Compliance score.
- Ensure all activities are carried out according to applicable control documents and project requirements.
- Mentor new joiners in the team as necessitated.
- Conduct knowledge sharing session/s and support in any organizational requirements.
- Adapt to different client case processing conventions and multi-task as per business needs.
- Perform ad-hoc tasks as advised by the team lead/manager with quality and compliance as per project requirement.
- Be aware of and comply with the PIMS Policy and GDPR requirements.
- Report any potential or actual security breaches to the regional and/or global DPO.
- Contribute towards achievement of PIMS Objectives.
Education, Experience and Skills:
- masters in science or above and in alignment with project / business team requirements.
- Minimum of 3 to 5 years of relevant experience in identified functional domain/ business workstream.
- Oncology and Rare disease case processing experience.
- Experience working in Argus safety database for Post Marketing, Literature, Investigator Sponsored Research, and Clinical Trials.
- Sound knowledge of Microsoft Office, specifically work in Excel
