Job description Schedule: Full-time • Conduct a full medical assessment of all serious and Non-Serious Cases; • Upgrade a Non-Serious Case to a Serious Case, where applicable, following the medical assessment; • Review and modify the data entered in respect of a Case as necessary and in accordance with applicable SOPs; and • Approve Serious and Non-Serious Cases. • Accenture shall assume the following responsibilities and perform the following activities with regard to Signal Detection: • Participate in Signal Detection meetings, as requested by Client; and • Provide client with line listings and summary tabulations for each Signal Detection Request.
Qualification : • MD/MBBS (board certified) as a minimum, a higher medical speciality is preferred; • A minimum of 2 - 4 years experience in a clinical practice; • A minimum of 1.5 - 3 years experience in pharmaceutical industry (PV, clinical Research, Medical Affairs areas of experience are preferred); • Thorough knowledge of Word and Excel required; • Experience in reviewing data listings and safety reports from clinical trials; • Sound medical knowledge; • Well organized, structured person, with a logic approach to issues raised; • Ability to comprehend and interpret clinical data; • Understanding of complexities of pharmacovigilance is preferred; • Commitment to quality and constantly seeking to improve it; • Understanding of pharmacovigilance regulations is preferred; • Excellent English oral and written skills are a must. • Ability to write and edit safety report;
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