Senior Drug Safety Specialist

Location
Rockville, MD, United States
Posted
Feb 08, 2021
Ref
1651507911
Hotbed
BioCapital
Required Education
Bachelors Degree
Position Type
Full time
Job Summary:

Senior Drug Safety Specialist will be responsible for providing drug safety and pharmacovigilance support for new and ongoing clinical trials. This individual will utilize clinical/pharmacovigilance judgment in coding of serious events and synthesizing complex clinical information into accurate and complete narratives. S/he will oversee specific PV outsourced activities and ensure that they produce a quality product and meet regulatory reporting requirements. This individual works under general direction.

Job Duties:
  • Reviews serious adverse event (SAE) reports to ensure accuracy, integrity and completeness of safety information, and to ensure consistency of medical coding of safety data. Reviews individual adverse event reports to ensure cases meet Company quality standards before submission to regulatory bodies and safety partners
  • Oversees outsourced activities including SAE management and safety database management in accordance with International Council for Harmonization (ICH) guidelines, Good Clinical Practices (GCP), and applicable regulatory guidelines and study procedures and GMI clinical development process
  • Ensures vendors produce quality outputs/tables from the safety database system (Oracle Argus to support safety review, DMC meetings and safety document creation.
  • Generates accurate and complete case narratives based on information received as part of source documents
  • Develops, participates and ensures the periodic internal safety review meetings/process
  • Contributes to the development, management and generation of SOPs for pharmacovigilance and drug safety monitoring. Evaluates and identifies areas that may require improvement or clarification and drafts procedural changes and adaptations as needed. Develops and implements internal pharmacovigilance guidelines, processes
  • Drafts responses to regulatory agency questions with regard to pharmacovigilance activities
  • Contributes to the development, management and generation of SOPs for pharmacovigilance and drug safety monitoring. Evaluates and identifies areas that may require improvement or clarification and drafts procedural changes and adaptations as needed. Develops and implements internal pharmacovigilance guidelines, processes
  • Participates in the development of relevant safety sections to the core data sheet, protocols, investigator's brochures, clinical study reports, product labeling/package insert, investigator communications and other clinical documents
  • Interacts with PV vendors and Regulatory Affairs to ensure appropriate reporting of pharmacovigilance and drug safety information to regulatory agencies and the prescriber community
  • May initiate corrective and preventive action (CAPA) measures following review of root cause analysis. Maintain and tracks all CAPAs
  • C omplies with all applicable policies regarding health, safety, and environment


Job Requirements:
  • BS in a scientific area or healthcare and a minimum of 8 years of progressively responsible experience in drug safety/pharmacovigilance in the biopharmaceutical industry; or equivalent. RN is preferred
  • Knowledge of pharmacovigilance processes and relevant SOPs
  • Must have demonstrated knowledge safety analysis and aggregate review risk management plans
  • Strong knowledge in FDA, EU, ICH guidelines, initiatives and regulations governing both safety reporting and processing for clinical trial environments. Demonstrated knowledge and experience in the regulatory requirements for clinical trial documents and reporting, including protocol development, data collection and analysis, and preparation of key medical documents supporting regulatory submissions for FDA and EMA
  • Experience with drug development and Phase I-III studies process and post marketing processes and regulations is required
  • Solid communication, writing, and interperson al skills with the ability to communicate technical information effectively verbally and in writing
  • Ability to work collaboratively and independently
  • Must demonstrate ethical principles and behavior
  • Strong planning and organizational skills; detail-oriented
  • Must be proficient in MSOffice (Word, PowerPoint, Excel) and other relevant software; ability to perform data retrieval and analysis via Oracle Argus
  • Ability to travel ~ 5-10%
    INDSJ2021