Shubha Shree M

Bengaluru

06.2023 - Current

Evaluating case validity.
Performed book-in and data entry of unstructured AE form in the client safety database.
Processing drug/device cases, including pregnancy cases, for various report types (spontaneous, non-interventional studies, incomplete, post-marketing surveillance).
Performed coding of adverse events, indications, and patient history based on the MedDRA browser, coding of suspect products and concomitant products using the Company drug dictionary and WHO drug dictionary as per the IPL (Integrated Product List) and VAP master list.
Clinically assessed case seriousness and causality.
Responsible POC for product specific processing for oncological drugs.
Upgrading and downgrading cases based on clinical judgment and on the basis of the EMA-IME list and CTCAE grading.
Narrative writing for initial and follow-up cases.
Identified follow-up requirements and drafted follow-up letters as per standard templates, as appropriate.
Actively participated in team discussions and facilitated knowledge refreshers to ensure team-wide processing updates.
Provided mentorship and guidance to newly onboarded team members in the field of ICSR, identifying opportunities for enhancement, and delivering constructive feedback to support their career development within the organization.
Peer reviewer of cases to ensure accuracy and compliance with regulatory requirements.