Global Lead, Pharmacovigilance (Remote-US)

Who We Are

Celebrating 40+ Years!

 

Theradex Oncology is a full-service CRO, conducting early and late phase oncology trials in the U.S, Europe and Asia. Theradex Oncology was founded in 1982, when we were awarded the Clinical Trials Monitoring Contract for the National Cancer Institute (NCI). Our ongoing association with NCI continues to be a strong basis for our operations. Our focus is cancer. We fully understand the science behind each potential cancer therapy and the challenges that come with moving therapies from mice to man. Theradex Oncology has designed and managed more than 250 early and late phase oncology trials to date. Our mission is to ensure that new discoveries in cancer drug development have the very best opportunity to be of benefit to mankind with a vision to improve treatment and make cancer a livable disease.   

What You'll Do

Global Lead, Pharmacovigilance - Remote Based - US 

 

We have a newly created position for a Global Lead, Pharmacovigilance to oversee the day-to-day operations of the global pharmacovigilance team in both the US & UK. In addition, you'll provide high-level planning along with expertise to management on pharmacovigilance issues. You'll interact with all levels of internal staff and external clients, including but not limited to sponsors, medical monitors, vendors, quality assurance auditors, study Investigators and site representatives.

 

The primary responsibilities of this position include, but are not limited to, the following:

• Oversee and manage all aspects of Theradex Oncology pharmacovigilance services
• Provide direct oversight of US and UK based pharmacovigilance personnel
• Responsible for all pharmacovigilance deliverables, including preparation and review of Safety Management Plans, Data and Safety Monitoring Plans and pharmacovigilance standard operating procedures
• Development and maintenance of a pharmacovigilance training curriculum
• Lead and manage sponsor pharmacovigilance-specific projects
• Contribute to study specific PV training materials, safety SOPS, work instructions and other study specific safety documents in collaboration with other PV and clinical team members
• Manage the processes of initial and follow-up SAE reports according to Theradex or Sponsor SOPs, the Safety Management Plan, or equivalent, and ICH guidelines view
• Review SAE reports and any supporting documents for accuracy and completeness and manage the preparation of SAE reports for assessment by the Medical Monitor for relatedness and expedited reporting 
• Collaborate with Medical Monitor for aggregate safety data review activities and coordinate safety surveillance activities 
• Coordinate the review of safety data by the Medical Monitors at pre-determined intervals
• Serve as a key liaison between the Clinical team, Sponsor, and third-party vendors for the management of adverse event reports for clinical studies
• Ensure a timely submission of pharmacovigilance reports (SUSARs and other safety communications) to regulatory authorities, ethics committees and investigators
• Contribute towards ongoing assessments of the safety of the product
• Notify the Sponsor of SAEs, as required, and follow-up with the investigational site personnel and CRA(s) to address queries for completing the SAE Report Form, medical assessment and reconciling the Theradex SAE and clinical databases
• Prepare safety reports (MedWatch/CIOMS) for Sponsor approval, regulatory submission, and investigator notification
• Reconcile the Theradex SAE and clinical databases and coordinate with data management and CRA to resolve discrepancies
• Work in collaboration with the Global Clinical team to maintain the pharmacovigilance section of the Trial Master File to ensure sections related to clinical safety are accurate and up to date
• Maintain study specific records for SAEs and safety reports, including the Theradex SAE database
• Ensure direct reports training records are up to date, including SOPs
• Participate in training, audit and inspection support
• Contribute to continuous improvement initiatives
• Develops PV goals, continued compliance and strategy for process improvement initiatives

What You Need

Level of Education

• Bachelor’s or master’s degree in pharmacy, nursing or in a life science field or equivalent
• Advanced degree preferred
• Medical background preferred

 

Prior Experience

• Minimum 5 years prior experience inclusive of prior clinical research/pharmacovigilance experience in positions of increasing responsibility required
• Oncology experience required