Senior Manager, Global Patient Safety Operations

1 week ago

Los Angeles, California, United States Planet Pharma Full time

NO PhD CANDIDATES WILL BE CONSIDERED FOR THIS POSITION

Remote

6 Month Contract (May extend or convert to permanent)

Candidates will be submitted at a competitive Market Rate (Depending on education, years of experience, and location)

The Opportunity:

  • This position will be responsible for managing, developing, and overseeing Global Patient Safety operational activities in the execution of safety information collection and reporting for the assigned clinical programs.
  • Participates in the development of Global Patient Safety Operations operational objectives, policies, and procedures.
  • Represent Global Patient Safety in different cross-functional team meetings. Collaborate with other functional groups to achieve clinical program goals.
  • Oversee Pharmacovigilance Contract Research Organization (PV CRO) in the execution of safety reporting in clinical studies.
  • Manage PV CROs to ensure compliance with required timelines, that potential issues are being communicated, and resolution is achieved in a timely manner.
  • Oversee reporting of safety reports to global regulatory authorities, central IRB/ethics committees, investigators to ensure compliance with global regulatory requirements.
  • Ensure timely and accurate set up of global safety reporting and safety database in assigned clinical programs.
  • Support authoring and updates of clinical trial protocols, informed consent forms, Investigator Brochure (including the Reference Safety Information section), and aggregate reports.
  • Support the execution and maintenance Safety Data Exchange Agreements/Pharmacovigilance Agreements with business partners.
  • Collaborate with other functional groups in SAE reconciliation and SAE query resolution activities.
  • Support Global Patient Safety team in other PV activities appropriate to experience and expertise.
  • May oversee or be responsible for one or more junior team member(s).

Required Skills, Experience and Education:

  • Completed bachelor's degree in a healthcare field and 7+ years of relevant experience in pharmacovigilance operational activities, OR, completed master's degree in a healthcare field and 5+ years of relevant experience in pharmacovigilance operational activities.
  • Hands-on experience working with Sponsors and CROs/vendors and management of external resources.
  • Strong background in safety reporting regulatory compliance and global safety reporting/regulations in clinical trials.
  • Able to problem solve, focus on details, multi-task, prioritize options, work independently, anticipate challenges and execute assigned deliverables.
  • Ability to analyze situations and data that requires conceptual thinking and in-depth knowledge of organizational objectives.
  • Ability to persuade others in sensitive/complex situations while maintaining relationships
  • An innovative team player with the capacity to be effective in a dynamic, continuously improving, and fast-paced company environment.
  • Excellent interpersonal skills, including the ability to work in cross-functional team environments and with external vendors.
  • Exercise discretion regarding highly confidential internal and external communications.
  • Experience working with investigator-sponsored trials, extended use programs, and business partnerships.

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