❖ 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
Pharm D. / Doctor of Pharmacy
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