Biotech/Pharmaceutical

Drug Safety Contractor – Remote

Contract

Penfield Search Partners

Contact: Neisha Camacho/Terra Parsons – teamnt@penfieldsearch.com

Job Description: The Drug Safety Contractor within the Clinical Safety and Risk Management (CS&RM) function is a seasoned professional with corresponding accountability expectations. This individual will manage surveillance of known or emerging safety issues, and participate in escalation processes, risk evaluation, and analysis of safety data. This position requires the application of broad knowledge of the drug development process to the CS&RM function and understanding the implications for post-marketing Pharmacovigilance. This individual will have a high degree of cross functional visibility within the clinical study teams as the Product Safety Lead for up to two molecules, with multiple protocols. This contract role can be remote or onsite, and will report to the Director, Clinical Safety & Risk Management.

Responsibilities:

  • Apply safety concepts and regulations contained within FDA CFR, ICH, and EU GVP to management of Safety data across the development life cycle
  • Analyze aggregate safety data within a clinical program towards tracking and trending of risk assessments and additional mitigation measures
  • Identify potential signals and escalate to the medical review function
  • Gather and analyze safety data for escalation to the Executive Safety Advisory Committee
  • Facilitate deliverables using strong project management/time management
  • Contribute to safety sections of the investigational new drug and new drug applications, investigator or regulator communications, Investigator brochure, and other reports (DSUR)
  • Participate in the set-up and maintenance of adverse event processes in global clinical trials
  • Perform Quality Review of the Individual Case Safety Report, including data and a concise, medically relevant narrative
  • Obtain clinically meaningful information from investigators to provide a robust safety assessment
  • Create and/or contribute to SOP development and “plan” documents within a clinical trial
  • Develop electronic case report forms, configure the Clinical database for Safety specifications, perform User Acceptance Testing, maintain documentation, and perform reconciliation with the clinical trial data
  • Act as a liaison internally and externally (e.g., Clinical Development, Regulatory Affairs, Biometrics, parent company and business partners) to develop programs and processes

Qualifications:

  • Required: RN with BSN, RhP, PharmD (no MDs)
  • Candidates must have signal detection experience
  • Candidates must have aggregate reporting experience
  • Clinical (patient care) experience is preferred
  • A minimum of 8 years’ experience in Drug safety or Pharmacovigilance
  • Ability to maintain an “inspection ready” environment
  • Ability to present, train, and/or explain processes to all levels of the organization
  • Demonstrated competency within a Safety Database; ARISg or ARGUS
  • Previous experience within an EDC system is desirable
  • Initiative, resourcefulness, accountability, and teamwork

Tagged as: Drug Safety Contractor - Remote