Executive, Pharmacovigilance & Drug Safety

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.