Theradex is a leading global oncology CRO in business for over 35 years is seeking a Pharmacovigilance (Drug Safety) Associate for our US headquarters based in Princeton, NJ. Serving the pharmaceutical and biotechnology industry and specializing in oncology, we are valued for quality monitoring, strong clinical expertise, and client satisfaction.
As part of our drug safety team, you’ll have the opportunity to be part of a collaborative and supportive environment. If oncology is your passion, Theradex is the place to develop your career while helping us in our mission to cure cancer.
What you’ll do:
The primary responsibilities of this position include, but are not limited to, the following:
- Implement Safety Management Plans (SMP) specific for the study protocol and Sponsor requirements.
- Manages the receipt and processing of SAE reports according to the Safety Management Plan, or equivalent document. This includes but is not limited to:
- Reviews SAE reports and any supporting documents for accuracy and completeness
- Enters safety data into the Theradex Safety Database
- Writes patient narratives
- Codes Serious Adverse Events accurately using MedDRA.
- Identifies significant missing information from reports and ensure its collection.
- Ensures case receives appropriate medical review.
- Prepares follow-up correspondence.
- Ensures cases that require expedited reporting to regulatory agencies are processed within the timelines identified in the SMP.
- Provides independent QC of SAE reports processed by the team
- Notifies the Sponsor and clinical team of SAEs, as required.
- Prepares safety reports for Sponsor approval, regulatory submission and investigator notification.
- Submits safety reports to regulatory agencies, Central Ethics Committees and Investigators, as required.
- Maintains study-specific records for SAEs and safety reports, including the Theradex safety database.
- Reconciles the Theradex Safety and clinical databases and coordinate with data management and Clinical Research Associates to resolve discrepancies.
- Contributes to the development of documents as related to safety (e.g. SOPs, protocols, etc.).
- Coordinates the review of safety data by the Medical Monitors at pre-determined intervals.
- Participates in signal detection, trend and pattern recognition activities, as appropriate.
- Actively participate in Pharmacovigilance team meetings.
- Provide after-hours monitoring and processing SAE reports, if required by sponsors
- Ensure audit preparedness and support regulatory inspections
- Maintain up-to-date knowledge of protocol and scope of work for assigned projects
What you need:
- Bachelor’s degree in a life science field or equivalent (e.g., Biological Sciences, Pharmacy, Nursing)
- 1-2 years Drug Safety experience or related (preferred)
- Case processing experience (preferred)
- SAE and SUSAR experience (advantage)
- Knowledge of medical and drug terminology
- Knowledge of Good Clinical Practice (GCP) related to clinical safety documentation
- High degree of accuracy with attention to detail
- Highly effective ability to anticipate problems relating to projects and to develop and implement solutions
- Excellent interpersonal skills
- Fluent knowledge of written and verbal English
- Highly organized and result-oriented
- Ability to work independently as well as in a team environment
- Proficient knowledge of Word and Excel
- Ability to provide weekend drug safety coverage on a rotating basis
What we offer: We offer a friendly and supportive culture that puts people first. We provide a competitive compensation and benefits package including medical, dental, vision, life insurance, STD/LTD, 401(k), tuition reimbursement, generous vacation/sick plans, flexible work schedules, employee discounts and much more.
This position does not offer company provided visa sponsorship or relocation assistance.
Theradex is an Equal Opportunity Employer.