Senior Pharmacovigilance Associate
Theradex Oncology
Summary
We are seeking a Senior Pharmacovigilance (Drug Safety) Professional. In this role, you will champion cross-functional collaboration with internal medical, data, and regulatory teams, as well as external vendors and auditors, to manage serious adverse events and guarantee regulatory compliance.
Job description
About the Role
We are seeking a Senior Pharmacovigilance (Drug Safety) Professional. In this role, you will champion cross-functional collaboration with internal medical, data, and regulatory teams, as well as external vendors and auditors, to manage serious adverse events and guarantee regulatory compliance.
Key Responsibilities
Study Setup & Document Development
- Prepare and implement study-specific Safety Management Plans (SMPs), Serious Adverse Event Report Forms (SAERFs), and completion manuals
- Contribute to the development of safety-related clinical documents, including SOPs and trial protocols
- Maintain up-to-date knowledge of the protocol and scope of work for all assigned projects
Case Management & SAE Processing
- Manage the receipt, tracking, and processing of SAE reports and supporting documents according to the SMP (including after-hours monitoring if required by sponsors).
- Review reports for accuracy, enter safety data into the Theradex safety database, write patient narratives, and code events accurately using MedDRA
- Identify significant missing information, prepare follow-up correspondence, and ensure all cases receive appropriate medical review
- Provide independent quality control (QC) of SAE reports processed by junior colleagues
Reporting, Submissions & Stakeholder Notification
- Ensure cases requiring expedited reporting to regulatory agencies are processed within SMP timelines
- Prepare safety reports for Sponsor approval, regulatory submission, and investigator notification
- Submit safety reports to regulatory agencies, Central Ethics Committees (CECs), and investigators, as required
- Notify the Sponsor and clinical team of SAEs according to project requirements
Data Reconciliation & Safety Surveillance
- Reconcile the Theradex Safety and clinical databases, coordinating with data management and CRAs to resolve discrepancies
- Coordinate the periodic review of safety data by Medical Monitors at pre-determined intervals
- Participate in signal detection, trend analysis, and pattern recognition activities
Trial Master File (TMF) & Audit Readiness
- Collaborate with the Global PV team to maintain the pharmacovigilance section of the Trial Master File
- Maintain study-specific records for SAEs and safety reports
- Ensure audit preparedness and provide direct support during regulatory inspections
Training & Team Collaboration
- Train and support junior colleagues, new staff, and general study team members on safety processes
- Actively participate in Pharmacovigilance team meetings
Requirements
- Bachelor’s degree in a life sciences field or equivalent (e.g., Biological Sciences, Pharmacy, Nursing) or relevant professional training and certification within the pharmacovigilance function
- 3-4 years Drug Safety experience or related
- Case processing experience
- SAE and SUSAR experience
- Prior experience with ARGUS safety database, including technical proficiency in XML generation, electronic gateway submission, and study/console configuration
- Willingness to be on call for after hours and weekend safety desk coverage
- Working knowledge of current EU and UK pharmacovigilance legislation, guidelines, and EudraVigilance systems
- Proficiency in MedDRA and WHO-DD coding dictionaries
- Excellent written, oral, and interpersonal communication skills
- English fluency: Full professional proficiency in written and verbal English
- Superior accuracy with strict attention to detail
- Proven ability to work productively both independently and within team environments
- Strong organizational skills and time management
- Advanced knowledge of Microsoft Word and Excel
Benefits
- Medical, Dental & Vision
- Life Insurance
- Disability Insurance (STD/LTD)
- 401(k) Matching
- Tuition Reimbursement
- Generous Vacation/Sick Plans
- Flexible Work Schedules
- Employee Discounts
Company overview
Theradex Oncology is a specialized full-service Contract Research Organization (CRO) focused exclusively on oncology clinical trials. Founded in 1982 and headquartered in Princeton, New Jersey, the company has over 40 years of experience supporting emerging biotech and pharmaceutical companies in cancer research. Theradex provides comprehensive clinical trial services spanning from pre-IND through Phase III studies, with expertise across all cancer indications and therapeutic modalities. Their team includes MD oncologists, regulatory experts, and experienced operational professionals who deliver focused, connected, and nimble support for clinical development programs. The company has established partnerships with the National Cancer Institute (NCI) and offers a wide range of services including clinical data management, monitoring, medical writing, pharmacovigilance, statistical design, and regulatory consulting. With global operations extending to the United Kingdom and Sweden, Theradex Oncology combines deep therapeutic expertise with operational excellence to accelerate oncology drug development.