Buenos Aires C.F.
Job Profile SummaryThe objective of this position is to provide medical expertise in the evaluation of safety data from a variety of sources as part of the overall pharmacovigilance process and determine the medical and scientific relevance of serious adverse event reports within the context of the product’s safety profile as well as other products within the same therapeutic area.Responsibilities• Perform medical review and clarification of trial-related Adverse Events (AEs) and post-marketing adverse drug reactions (ADRs) including narrative content, queries, coding, expectedness, seriousness, causality and company summary • Compose, edit and medically review Analyses of Similar Events (AOSE)
for expedited cases as appropriate based on regulatory requirements• Provide coding review of AEs, SAEs, SADRs, Past medical history, Concomitant medications or other medical data listings to verify and medically vet clinical data. • Serve as an internal consultant to pharmacovigilance case processing teams on projects being supported• Perform medical safety review of the protocol, Investigative Brochure, and/or Case Report Forms (CRFs) for appropriate safety content and data capture, as applicable. • Provide aggregate reviews of safety information, including but not limited to clinical data, postmarketing, literature review and observational studies to maintain oversight of a product’s safety profile (e.g: DSUR, RMP, PBRER, ad hoc regulatory reports etc)• Ensure service delivery from productivity, compliance and quality perspective within regulatory /contracted timelines. Lead and participate in the initiatives taken for the same from team delivery perspective• Provide therapeutic area/pharmacovigilance issue guidance in the context of leading/managing other safety team members in single case assessment. • Attend project meetings, medical safety team meetings, and represent safety and clinical data review findings during client meetings, as applicable• Act as Lead Safety Physician, or additional team support, and/or back up on assigned projects as applicable. • Provide medical escalation support for medical information and EU Qualified Persons for Pharmacovigilance projects, as applicable • The position will be for 6-12 months working full- time (40hs weekly hours).Qualifications:• Medical Degree from an accredited and internationally recognized medical school with a curriculum relevant to general medical education, along with a medical license, or equivalent, from the country or region in which he/she resides and works is required.• Interested to get experience in Research Clinical Industry in Safety area.• Interested to work full-time for a 6- 12 months contract.• Strong English communication skills. (both written and spoken).
Muestra tus habilidades a la empresa, rellenar el formulario y deja un toque personal en la carta, ayudará el reclutador en la elección del candidato.
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