Masters degree in Microbial Biology, Pharmacy, or related field 2 years of experience involving the followingbr Ability to utilize the medical dictionary for regulatory activities terminologybr to investigate the safety database for evaluation of safety signals from clinical studies, postmarket, solicited, or literature sources;br Directing, advising, reviewing, authoring, or knowledge of safety sections of aggregate data reports such as periodic benefitrisk evaluation report, periodic safety update report, periodic adverse drug experience report, or development safety update report in accordance with international council for harmonization of technical requirements for pharmaceuticals for human use guidelines; Analyzing, employing, or investigating scientific and medical data in verbal and written format;br Utilizing softwarebased drug safety systems such as Argus or Rave; and Analyzing scientific literature databases such as Biosis, Embase, or OVID.br br Section H.14 defines the experience and skills that a qualified candidate must possess to meet the actual minimum requirements for the position. This experience and skills may be obtained in the position offered or any alternate related occupation, regardless of job title.
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