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Lead, Drug Safety and Pharmacovigilance

Aventura, FL
Headquartered in Aventura, Florida, with regional offices and operations across North America and around the world, Biorasi is an award-winning fast growing, full-service, global CRO that delivers Clinical Research Optimized™ to the world's leading biotech and pharmaceutical companies.

Biorasi hires talent and personality, not position holders.  We’re a non-traditional work environment requiring only top performers.  Every team member is a stock-holding owner and our culture reflects it.

Unlimited potential for professional, financial and personal growth. If you are after broad and growing responsibilities coupled with full authority, are keen on doing the job your way, without bureaucracy getting in the way of key decisions, and truly believe that a well-structured operational infrastructure is one of the key components to a company’s success, then this unique opportunity is for you.

This is a remarkable opportunity to dedicate yourself to leading a vital function of a growing company and benefiting professionally and financially from your accomplishments. If you have an entrepreneurial mind-set, a passion for achievement and are looking for a place to explore your potential, Biorasi wants to talk to you now.

Responsibilities
  • Identify incomplete Safety Reports (those which are not suffice Minimum Required Information) generate queries.
  • Enter SAE report data into the Safety Database and generate SAE narrative
  • Code applicable verbatim terms using MedDRA and WHO-DD dictionaries.
  • Notify Sponsor and Medical Monitor by generating and distributing a Reportability Assessment Form along with attachments (Safety Reports, medical records, etc.). Notification must be sent within 24-hours.
  • Assists the Clinical teams with issue resolution as it relates to safety issues.
  • Coordinates with the study Medical Monitor or perform Medical Monitoring duties, as needed.
  • Participate in the development of Medical Writing deliverable, including SAE narratives, Clinical Protocols, Clinical Study Reports, Investigator’s Brochures, Informed Consent Forms, etc.
  • Communicates any out-of-scope issues to the VP, Drug Safety and Pharmacovigilance or designee as soon as identified.
  • Participate in the Development of Drug Safety and Pharmacovigilance Standard Operating Procedures (SOPs), forms, templates and working instructions.
  • If there is a mismatch between database preventing reconciliation ,generate safety query, review the received  SAE reports and generate a query in the EDC system if required.

Qualifications
  • Bachelor’s degree (Health Sciences, Pharmacy, Nursing, Biomedical sciences or related scientific discipline background) or its international equivalent.
  • Good critical thinking, verbal, writing, and oral presentation skills.
  • Understanding of ICH/GCP regulatory environment and requirements.
  • Computer literacy with proficiency in Microsoft Office.
  • Experienced with Safety databese (ARISg , Oracle, Argus etc.) Preferred.
  • Experience with safety databases (ARISg, Oracle Argus, etc.) preferred.
  • 1-2 years of experience in either a pharma/biotech/CRO setting preferred.
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