- Review clinical trial protocol for safety language, pregnancy language, safety reporting requirements (SAEs/SSRs/ESIs), including reporting method, types of events and timelines depending on the drugs involved and the patient population.
- Lead project and monitor the clinical trial, ensuring it is complaint with safety procedures and reporting.
- Answer and address safety related concerns and assist in the set-up of new safety projects, including development of study-specific Safety Management Plans in clinical trials.
- Prepare slides and present safety reporting requirements for clinical trials at kickoff meetings with CRO and at investigator meetings.
- Review case record forms (CRF), case record form completion guidelines, clinical data management plan, data quality review plan, protocol, CRO agreements & SAE process flows
- Determine regulatory reporting requirements (FDA) and setup clinical trials for safety reporting. Determine the need for contracts/agreement with CROs for safety reporting depending on country requirements and ethics submissions.
- Process all safety reports received from any source (clinical trials and post- marketing) for assigned products and studies in safety database ARGUS, write medical narrative for submission, according to ICH-GCP guidelines, regulatory requirements and company SOPs, policies and procedures.
- Perform case assessment and ensure entire study procedures from design, conduct and closeout are carried out according to the approved study protocol, applicable regulatory requirements (FDA), ICH-GCP guidelines, appropriate SOPs and in compliance with company policies.
- Review and supervise code medical events based MedDRA or Medical Dictionary for Regulatory Activities and code drugs based on WHO drug dictionary.
EDUCATION : MD or MS Biological Science or Pharmacology and 2 years of Exp in Clinical Research
EXPERIENCE: 2 years experience in Clinical Research
Aspiring Candidates can Mail Resume to:
THE VERITAS HEALTHCARE SOLUTIONS, LLC
469 7th Ave, 7th Floor
New York, NY 10018