(WVO389) - Sr Medical Safety Advisor

(WVO389) - Sr Medical Safety Advisor

16 sep
|
Iqvia
|
Buenos Aires

16 sep

Iqvia

Buenos Aires

IQVIA™ is the leading human data science company focused on helping healthcare clients find unparalleled insights and better solutions for patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness the power of healthcare data, domain expertise, transformative technology, and advanced analytics to drive healthcare forward.

Job Profile Summary The 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. Also, 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. • Ensure update of watch list, list of expectednsess, labeling list/RSIs etc for the assigned products and develop such additional capabilities within the team. • Lead, drive and participate in training activities, product transitions, audit preparation and knowledge exchange initiatives. • Review and sign off on the Project Safety Plan and Medical Monitoring Plan per medical safety scope agreed in contract, as applicable. • 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 • 24 hour medical support as required on assigned projects Join Us Making a positive impact on human health takes insight, curiosity, and intellectual courage. It takes brave minds, pushing the boundaries to transform healthcare. Regardless of your role, you will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve outcomes for patients. Forge a career with greater purpose, make an impact, and never stop learning.

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