Senior Executive/Specialist

About ClinChoice

ClinChoice is a partner to the largest pharmaceutical, medical device, and consumer care innovators in the world. Established in 1995, we provide expertise in clinical operations, biometrics, regulatory affairs, pharmacovigilance, medical affairs, and toxicology to help our partners advance healthcare by accelerating clinical trials with data-driven insights, delivering the best strategies for product registration, and enhancing patient safety through real-world and clinical analysis. Our global delivery network has expanded to centers and satellite offices in the United States, Mexico, United Kingdom, Armenia, China, Japan, India, Italy, Poland, Canada and the Philippines to help our customers maintain regulatory compliance locally and globally. We have forged future-defining partnerships with industry bodies and technology companies to develop cutting-edge solutions that deliver our expertise with quality and precision.

Primary 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.

• Complete all assigned training, both internal and client initiated, within specified due dates.

• Conduct knowledge sharing session/s and support in any organizational requirements.

• Be aware of and comply with the PIMS Policy and GDPR requirements.

• Contribute towards achievement of PIMS Objectives.

Candidate's Profile

• Master's 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.

• 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.