WE ARE LOOKING FOR AN EXPERIENCED DRUG SAFETY ASSOCIATE II TO JOIN OUR TEAM!

The Drug Safety Associate II candidate will work in a team-oriented, dynamic, and collaborative environment. This person will be responsible for providing drug safety expertise and ensuring accurate and timely documentation of safety data, particularly serious adverse events (SAEs). This role will support all major tasks related to the management of case processing activities, ensuring compliance with global clinical safety and pharmacovigilance regulations.
Remote applicant are welcome to apply.

QUALIFICATIONS:

• Healthcare professional degree (i.e., RN, PharmD) with minimum of 3 years professional experience or Bachelors’ degree in life sciences or equivalent relevant scientific qualifications with minimum of 3 years of experience in drug safety
• Knowledge of global safety regulations, ICH Guidelines, and other applicable regulatory guidance documents
• Experience using Argus safety database preferred
• Clinical trial and adverse event processing experience
• MedDRA training and experience
• Excellent interpersonal and communication skills, both written and oral
• Excellent proficiency in MS Office Suite (Excel, Power point and Word)
• Cardiovascular experience or knowledge preferred
• Ability to prioritize workload
• Ability to assess data and understand the medical/safety implications
• Demonstrated success working both independently and in collaboration with others
• Strong attention to detail, commitment to quality and accuracy
• Strong organizational skills and ability to adapt to change
• Ability to follow guidelines and procedural documents
  Note: Viable applicants will be required to pass a background and education verification check.
  Targeted Compensation: $64,000 - $76,000 annually
  Deadline to Apply: August 1, 2025

DRUG SAFETY RESPONSIBILITIES:

• Support all drug safety aspects of studies managed by CPC.
• Process and assess adverse events from receipt to case closure, including query generation and narrative writing.
• MedDRA and WHODrug coding, as needed.
• Update and manage various safety workflows as well as submission trackers.
• Perform safety case management including receipt, duplicate check, tracking, assessment of seriousness and expectedness, data entry and narrative writing.
• Interpret case-related information including medical conditions, lab results, and procedures, as well as compile complete narrative summaries.
• Review data to ensure case accuracy with minimal error in narratives.
• Review, enter, and verify follow-up information for cases and make accurate determination of significant information.
• Perform review of ancillary documentation accompanying ICSR reports and identify pertinent information for incorporation into the case narrative.
• Correctly identify cases requiring targeted follow-up, and determine relevant follow- up queries.
• Meet specific data and quality targets for case handling.
• Liaise with safety physicians, medical monitors, sites, vendors, or other organizations as needed on safety data issues.
• Collaborate with other CPC departments (e.g., Research Operations, Data Management, etc.) to ensure appropriate collection and handling of safety data.
• Training of new safety staff on databases and case processing.
• Organize workload to ensure departmental workflow processes and timelines are followed.
• Support PV Audit and Inspection preparation as needed.

GENERAL RESPONSIBILITIES:

• Identify and implement methods, techniques, procedures and evaluation criteria to achieve results.
• Perform a variety of complicated tasks with some degree of creativity and latitude.
• Remain current with CPC SOPs, guidance documents and database technology.
• Perform Quality Control on other team member’s work as needed.
• Participate in other activities as needed or as requested by the supervisor.