Associate ICSR Submissions

Position: Associate   ICSR Submissions
Location: Bengaluru

Job Description

Job Description:

Review cases in the ICSR Submission workflow :
Evaluate incoming safety reports to identify relevant information and ensure that all necessary data is available for reporting.
Check if ICSRs meet reporting requirements to the Health Authority :
Assess each case against established regulatory criteria to determine if it is reportable to health authorities, ensuring compliance.
Perform local data entry as required :
Input necessary information into the safety database accurately and promptly, ensuring that all case details are captured for effective tracking and reporting. Attach any necessary documents (literature articles) for reporting.
Ensure cases are submitted within timelines to meet compliance :
Monitor submission deadlines closely to guarantee that all reportable cases are submitted on time, thereby adhering to regulatory timelines
Collaborate with internal teams regarding case status and submission issues :
Communicate effectively with cross-functional teams, such as DDIT, to resolve any issues related to case processing and submission.
Prepare reports for internal and external stakeholders as required :
Generate comprehensive reports summarizing submission activities and case statuses for various stakeholders, ensuring transparency and effective communication within the organization
Strategic Impact:
Contributes to or even impacts the results of own team. Exchanges straightforward information, asks questions and checks for understanding.

Education:

Bachelor's/Master's degree in Pharmacy
Strong experience in Pharmacovigilance