Executive, Pharmacovigilance & Drug Safety

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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