Drug Safety Manager

Job Description

A drug safety manager, also known as a pharmacovigilance manager, is primarily responsible for overseeing all aspects of drug safety within a pharmaceutical company, including monitoring adverse events, identifying potential safety signals, conducting risk assessments, ensuring compliance with regulatory requirements, and taking appropriate actions to mitigate risks to patient safety.
• Reviewing and evaluating adverse event reports (AERs) received from clinical trials and post-market surveillance.
• Conducting risk assessments to evaluate the benefit-risk profile of a drug.
• Ensuring adherence to all applicable regulatory requirements regarding drug safety reporting.
• Leading and managing a team of drug safety professionals (e.g., drug safety associates, clinical safety scientists).
• Communicating safety concerns to internal stakeholders (e.g., clinical development teams, medical affairs).
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Keyskills :
clinical monitoringclinical researchclinicaltrialsclinical research associatesclinical data management