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.   

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

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
• Strong prior management experience required leading direct reports
• Experience of working with ARGUS safety database and EudraVigilance and/or XEVMPD user certification would be a plus

Skills and Competencies

• Thorough knowledge of current US, European Union, and United Kingdom legislation and regulatory requirements as outlined in EudraVigilance and federal regulations and applicable guidelines and guidance, particularly those dealing with pharmacovigilance, study monitoring and good clinical practice
• Detailed and thorough knowledge and application of ICH-GCP requirements
• Knowledgeable of MedDRA and WHO-DD Coding
• Ability to prioritize tasks in order to meet deadlines, multitasking and working well under pressure
• Highly developed leadership skill
• Fluent knowledge of written and verbal English
• Excellent communication skills (both written and oral) 
• Proficient computer skills (minimum: Word, Excel and PowerPoint)
• Highly effective ability to set and meet personal short- and long-term goals
• Highly effective ability to anticipate problems relating to projects and to develop and implement solutions
• Strong analytical, problem solving and technical skills
• Create a learning environment, is approachable and available
• Excellent interpersonal skills
• Highly organized and result-oriented
• Ability to work independently as well as in a team environment

Additional Requirements:

• May require a limited amount of travel for meetings as needed (advance notice will be provided should the occasion arise)  
• Valid Driver’s License
• Membership in American Society of Clinical Oncology preferred

What We Offer

We offer a supportive culture that puts people first. We provide a competitive compensation and benefits package including medical, dental, vision, life insurance, STD/LTD, company matched 401(k), very competitive tuition reimbursement, generous vacation/sick plans, flexible work schedules, employee discounts and much more.   

Sponsorship or relocation is not offered for this position.

Theradex is an Equal Opportunity Employer.

No agencies.