Senior Pharmacovigilance Associate

Celebrating 40+ years!

Theradex Oncology is a full-service CRO specializing in oncology. The company manages global oncology trials and programs. The company was founded in 1982 working with the National Cancer Institute, which led to its expansion to working with industry sponsors developing cancer therapeutics. As a service-based company we support both domestic and international sponsors in the conduct of both early and late phase trials.

As part of Theradex Oncology, you will have the opportunity to work with one of the largest professional teams focused solely on the development of cancer therapies. Cancer research continues to evolve as new therapies and therapeutic approaches are discovered, as part of the team you will work to support our sponsors in the development of these therapies. Theradex Oncology is an environment for highly motivated individuals who want to make a difference.

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

Qualifications

Required:

• 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

Preferred:

• Eudra Vigilance and/or XEVMPD user certification is a plus
• Previous experience with randomized blinded studies and automation functionalities in ARGUS

Skills and Competencies

Pharmacovigilance & Regulatory Expertise

• Maintaining strong operational mastery
• Working knowledge of current EU and UK pharmacovigilance legislation, guidelines, and Eudra Vigilance systems
• Thorough knowledge and application of requirements,…