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Medical Safety Operations Manager/Senior Manager

Redwood City, CA 94063

Posted: 05/03/2023 Employment Type: Contract Job Category: Pharmacovigilance Job Number: 561133 Is job remote?: No Country: United States

Job Description

The Opportunity:
Market Rate

As a Medical Safety Operations Manager/Senior Manager, you will be responsible for the management and oversight of Medical Safety functional activities in the execution of safety reporting for the assigned clinical programs.
  • Representing Medical Safety in different cross-functional team meetings.
  • Collaborating with other functional groups to achieve clinical program goals.
  • Overseeing Pharmacovigilance Contract Research Organization (PV CRO) in the execution of safety reporting in clinical studies.
  • Managing PV CROs to ensure compliance with required timelines, that potential issues are being communicated, and resolution is achieved in a timely manner.
  • Overseeing reporting of safety reports to global regulatory authorities, central IRB/ethics committees, and investigators to ensure compliance with global regulatory requirements.
  • Ensuring timely set up of global safety reporting and safety database in assigned clinical programs.
  • Supporting authoring and updates of clinical trial protocols, informed consent forms, Investigator Brochure (including the Reference Safety Information section), and aggregate reports.
  • Supporting the execution and maintenance of Safety Data Exchange Agreements
/Pharmacovigilance Agreements with business partners.
  • Collaborating with other functional groups in SAE reconciliation and SAE query resolution activities.
  • Supporting medical safety team in other PV activities appropriate to experience and expertise.
Required Experience, Skills, and Education:
  • Bachelor’s degree in a healthcare field with a minimum of 3-6 years of pharmacovigilance operational activities.
  • Strong experience working with CROs/vendors and management of external resources.
  • Strong background in safety reporting regulatory compliance and international safety reporting/regulations in clinical trials.
  • Experience in working with global clinical trials, investigator-sponsored trials, compassionate use programs, and business partnerships is preferred.
  • Able to problem solve, multi-task, prioritize options, work independently, anticipate challenges, and execute assigned deliverables.
  • Attention to detail and excellent written and verbal communication skills.
  • 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.
  • Software Knowledge: MS Office 365 (Outlook, Word, PowerPoint, Excel), Adobe Acrobat.
  • LOCAL candidate is preferred.
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