Job Description

:

? Prepare and maintain the Signal Schedule as per Standard Operating Procedures.


? Identification, Analysis, and Evaluation of safety signals arising from various data sources to determine signals or risks that could result in changes to labels and / or benefit-risk profile of the product.


? Evaluate the safety information and prepare product specific ADR (Adverse Drug Reaction) Sheet.


? Author Drug Safety Report (DSR) for Valid signals as per Standard Operating Procedures.


? Communicate findings from routine and ad hoc signal detection and assessment activities to concerned stakeholders.


? Contribute to cross-functional initiatives aimed at improving pharmacovigilance capabilities related to signal detection.


? Maintain awareness on new or revised regulatory requirements and guidelines relevant to Signal Management.


? Ensure regulatory compliance (quality, procedures, regulations, timeliness, consistency) for Signal Management process.


? Assist in preparation/revision of SOP, Work instructions, templates and guidance training documents concerning Signal Management.


? Impart trainings related to Signal Management activities, as and when required

Skills Required:

Regulatory Medical Writing | Intermediate Medical Literature Review & Analysis | Intermediate Adverse Event Reporting & Signal Detection | Advanced Regulatory Affairs Collaboration | Intermediate Safety Data Analysis & Visualization | Advanced

Qualification - B. Pharm



Amneal is an equal opportunity employer. We do not discriminate based on caste, religion, gender, disability, or any other legally protected status. We believe in fostering a workplace that values diversity and inclusion.