Join ClinChoice: Exciting Opportunities in Pharmacovigilance – Apply Now

About the Company (ClinChoice):

ClinChoice is a global contract research organization that provides comprehensive services to the pharmaceutical, biotechnology, and medical device industries worldwide. With over 2,000 employees across the globe and key offices in the US, UK, China, India, Armenia, Japan, and the Asia-Pacific region, ClinChoice offers expertise in data management, biostatistics, clinical operations, regulatory affairs, pharmacovigilance, and more. Established in the US in 1995, ClinChoice continually strives for excellence, ensuring accuracy and efficiency in delivering the highest quality output for its customers.

Company Vacancies List:

Position Title: Senior Executive – Case Processing
Company Name: ClinChoice
Role: Senior Executive – Case Processing
Industry Type: Contract Research Organization (CRO)
Department: Pharmacovigilance
Employment Type: Full Time
Role Category: Clinical Research
Educational Background Required: Master’s in science or above

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.
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.

Secondary Responsibilities (if applicable – delete if not used):

Be aware of and comply with the PIMS Policy andGDPR requirements.
Report any potential or actual security breaches to the regional and/or global DPO.

Contribute towards achievement of PIMS Objectives

Minimum Qualifications

· 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.

· 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

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Clinchoice hiring Pv Senior Executive - Case Processing — Clinchoice hiring Pv Senior Executive – Case Processing