Drug Safety Associate

1 week ago


Bengaluru, India Seven Consultancy Full time

Job Description - Ensure that safety reports received from investigational sites or post-marketing sectors are identified and reported in accordance with ICH-GCP standards and standard operational procedures. - Organize collected reports based on the seriousness or effectiveness of the drug. - Maintain consistency in assessing adverse reaction reports accurately and legibly. - Apply knowledge of FDA and ICH-GCP regulations to make appropriate decisions. - Communicate effectively with clinical physicians regarding drug safety and assess case report forms. - Distinguish and analyze the ratio of risks and benefits of marketed drugs.


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