Clinical Case Processing Associate

2 days ago

Kochi Kerala, India ChiSquarelabs Full time

Job Title: Clinical Case Processing Associate

**Job Type**: Full-Time, Mid-Senior Level ,Hybrid

Key Responsibilities: - Conduct a thorough review of patient charts from diverse EHR systems and map them to suitable clinical studies based on predefined study criteria, ensuring a consistent volume of cases is reviewed to meet performance standards. - Contribute to the advancement of therapeutic knowledge and promote collaboration within the team for optimal productivity. - Handle adverse events, including data entry, medical coding, and narrative writing, with a focus on serious, non-serious, and unexpected adverse events to ensure comprehensive reporting. - Prepare and submit Individual Case Safety Reports (ICSRs) and periodic reports to regulatory authorities within the required timelines to ensure compliance with reporting standards. - Ensure adherence to local and global regulatory requirements, including timelines for case reporting. - Liaise with stakeholders to ensure effective communication and alignment on case processing activities. - Foster collaborative productivity within the team to support knowledge sharing and quality outcomes.

Qualifications and Skills: - Bachelor’s degree in Life Sciences, M Pharm/Pharm D, Medicine, or a related field. - 1 - 2 years of experience in pharmacovigilance, clinical research, safety case management, or a related role (preferred). - Proficiency in safety databases such as Argus, ARISg, and Veeva. - Experience with medical coding systems, including MeDRA and WHO-DD. - Knowledge of regulatory guidelines including EMA, ICH-GCP, FDA, and GVP, along with a solid understanding of pharmacovigilance processes. - Strong attention to detail, organizational, and time management skills. - Excellent written and verbal communication skills

Schedule:

- Day shift

Application Question(s):

- Notice period to join

**Experience**:

- pv: 1 year (required)

**Language**:

- English (preferred)

Work Location: In person

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