Senior Pharmacovigilance Specialist

3 days ago

kollam, India beBeeMedical Full time

We are seeking a highly skilled Medical Safety Physician to join our team.The ideal candidate will have experience in drug safety and pharmacovigilance with strong knowledge of medical and therapeutic terminology.The primary responsibilities include:Reviewing and assessing individual case safety reports obtained from clinical trials, spontaneous and solicited reports.Determining regulatory reportability of cases obtained from clinical trials, spontaneous and solicited reports within assigned therapeutic teams and across all products/sites.Performing triage of cases and determining seriousness and relatedness across products as assigned.Reviewing and verifying appropriate selection of adverse events from source documents, assigning appropriate MedDRA code, assessing labeling, and reviewing narrative.The secondary responsibilities include:Having strong competence with medical and therapeutic terminology.Understanding of Patient Safety regulatory obligation.Good attention to detail.Ability to deliver within established timelines.Fluency in Spoken and written English and excellent comprehension.Qualifications include an MBBS or MD degree and 1-2 years of experience in pharmacovigilance with minimum 2 years of clinical experience.

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