Senior Pharmacovigilance Associate

Theradex Oncology; Princeton (NJ); A distancia; USD 80.000 - 115.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Medical, Dental, Vision

Life Insurance

401(k) matching

Descripción de la vacante

Theradex Oncology is seeking a Senior Pharmacovigilance Professional to lead cross-functional collaboration with internal medical, data, and regulatory teams, as well as external vendors and auditors, ensuring regulatory compliance for SAE management.

The role emphasizes study setup, document development, and rigorous data reconciliation, with responsibilities spanning case processing, reporting, and TMF maintenance. Strong MedDRA/WHO-DD knowledge and ARGUS experience required.

Formación

• Bachelor’s degree in a life sciences field or equivalent.
• 3–4 years Drug Safety experience or related.
• SAE and SUSAR experience.

Responsabilidades

• Study Setup & Document Development: Prepare SMPs, SAERFs and completion manuals; contribute to safety documents and SOPs.
• Case Management & SAE Processing: Manage SAE reports, enter data in safety database, code events in MedDRA; QC of SAE reports.
• Reporting, Submissions & Stakeholder Notification: Expedite reporting; prepare safety reports for sponsor and regulators; notify team of SAEs.
• Data Reconciliation & Safety Surveillance: Reconcile safety databases and coordinate with data management; periodic review by Medical Monitors; signal detection.
• Trial Master File & Audit Readiness: Maintain PV section of TMF; ensure audit preparedness and support inspections.
• Training & Team Collaboration: Train junior staff; participate in PV team meetings.

Conocimientos

Pharmacovigilance

Regulatory compliance

MedDRA coding

WHO-DD coding

Cross-functional collaboration

English fluency

Educación

Bachelor's degree in life sciences

Herramientas

ARGUS safety database

XML generation

Electronic submissions

Descripción del empleo

Who We Are

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.

What You'll Do

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.

Location: Remote US - Preference will be given to candidates residing in East Coast or Central Time zones.

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

What You Need

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:

• EudraVigilance 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 EudraVigilance systems
• Thorough knowledge and application of requirements, including clinical safety documentation
• Proficiency in MedDRA and WHO-DD coding dictionaries
• Deep understanding of specific sponsor and client internal Standard Operating Procedures

Analytical & Problem-Solving Skills

• Strong analytical and technical skills to anticipate project roadblocks and implement proactive solutions
• Ability to set, track, and achieve short- and long-term project goals

Communication & Language Proficiency

• Excellent written, oral, and interpersonal communication skills
• English fluency: Full professional proficiency in written and verbal English

Operational Excellence & Tools

• 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

What We Offer

At Theradex we offer a supportive culture that puts people first. Our employees are eligible to participate in our comprehensive benefits package which includes medical, dental and vision coverage; life insurance, disability insurance (STD/LTD), company matched 401(k), very competitive tuition reimbursement, generous vacation/sick plans, flexible work schedules, employee discounts and other company provided benefits. The annual base salary for this position ranges from $80,000-$115,000. The actual salary offer will be based on a number of factors, including but not limited to the candidate’s qualifications, experience, skills, and competencies for the role.

This position is not eligible for relocation or company provided sponsorship.

Theradex is an Equal Opportunity Employer.