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Clovis Oncology, Inc. Director, Pharmacovigilance Global Clinical Trials Operations in Boulder, Colorado

Job Summary

The Director will lead all PV Clinical Trial Operations. The Director will take responsibility for promoting a culture of reporting excellence within Clovis Oncology Pharmacovigilance. Pays a high level of attention to detail, understanding the advantages of a highly structured working environment as it applies to Clinical Trial case management, while maintaining the development and refinement of an already highly-performing unit to meet the demands of an expanding clinical trial portfolio.

The Director develops departmental budgets, and performance metrics and ensures that all requirements are met.

The Director will take pride in leading a case management group that consistently reports safety in a fully compliant manner, with safety reports that are clinically informative and useful to colleagues, external assessors and investigators. The Director will be able to embrace the challenges and opportunities offered in a small company environment and to capitalize on the experience to develop skills and attain career goals.

Job Responsibilities

  • Lead and manage activities of the PV Clinical Trials Operations team, including global case processing, CRO oversight, and PV training and compliance

  • Line manage the PV Clinical Trials Operations staff using regular 1:1 meetings/calls and group meetings. Be prepared and able to identify and remediate performance issues, as well as to recognize potential and develop it

  • Ensure global clinical trials case reporting is efficient and compliant with reporting requirements detailed in the safety management plans (SMP), PV agreements, and safety data exchange agreements

  • Estimate budget required for external clinical trial case processing spend, and run activities to budget

  • Estimate FTEs required for clinical trial case processing using data/metrics generated from ongoing safety reporting activities

  • Oversee the configuration and maintenance of the pharmacovigilance database for clinical trials

  • Oversee aggregate report activities that include, but not limited to, generation of listings from the pharmacovigilance database, distribution to the applicable CROs and safety vendor, and tracking of completed submissions

  • Oversee deviation and CAPA activities in relation to, but not limited to, late SUSAR or aggregate report submissions as well as deviations relating to case management processes as defined per the SMPs or SOPs

  • Produce monthly reporting metrics

  • Develop/update SOPs as required

  • Participate in inspections and audits as the Clovis PV Clinical Trials Operations expert

  • Interface with Senior Management to ensure consistency of PV strategy with corporate goals

Qualifications

  • Detailed knowledge of current FDA and EMA safety reporting regulations related to study conduct and reporting

  • Able to oversee clinical trial case management in other territories (e.g. Japan, E Europe) by partnering with appropriate external organizations

  • High level of communication (written and verbal), interpersonal, organizational, and cross functional collaboration skills

  • Knowledge of GCP and ICH Guidelines

  • Proficient in Microsoft Work, Excel, and PowerPoint

  • Flexibility to work with colleagues in a global setting

Education and Experience

  • Bachelor’s degree or higher, or an equivalent Healthcare professional qualification.

  • 10+ years of experience leading and managing safety associates/professionals with a minimum of 5 years’ experience in a drug safety role in the pharmaceutical industry including:

  • Hands on experience of safety reporting database(s) and familiar with applicable coding dictionaries

  • Experience with ARGUS safety database an advantage

Working Conditions

  • Office-based position with occasional travel to the Boulder, CO offices.

  • Able to engage in work-related travel when required (estimated once/quarter to the other US office, either San Francisco or Boulder)

Qualifications

  • Detailed knowledge of current FDA and EMA safety reporting regulations related to study conduct and reporting

  • Able to oversee clinical trial case management in other territories (e.g. Japan, E Europe) by partnering with appropriate external organizations

  • High level of communication (written and verbal), interpersonal, organizational, and cross functional collaboration skills

  • Knowledge of GCP and ICH Guidelines

  • Proficient in Microsoft Work, Excel, and PowerPoint

  • Flexibility to work with colleagues in a global setting

Education and Experience

  • Bachelor’s degree or higher, or an equivalent Healthcare professional qualification.

  • 10+ years of experience leading and managing safety associates/professionals with a minimum of 5 years’ experience in a drug safety role in the pharmaceutical industry including:

  • Hands on experience of safety reporting database(s) and familiar with applicable coding dictionaries

  • Experience with ARGUS safety database an advantage

Working Conditions

  • Office-based position with occasional travel to the Boulder, CO offices.

  • Able to engage in work-related travel when required (estimated once/quarter to the other US office, either San Francisco or Boulder)

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