Medical Safety Advisor (Part time or Free Lance) HOMEBASED

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.

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 FullHomebased for 6 months with the possibility to work part- time (4hours) or as a Free Lancer.

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 part time or as a Frelancer for a 6 months contract.
• Strong English communication skills. (both written and spoken).

At IQVIA, we believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. The advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our 67,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com.