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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.

The staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.

Planet Pharma and The Planet Group of Companies are equal opportunity employers. It is our practice not to discriminate against any employee or applicant based on any criteria, condition or basis protected by laws or regulations in the locations where we do business. All qualified applicants are encouraged to apply. We celebrate diversity and are committed to providing an environment of mutual respect. We believe that diversity, equity and inclusion enable us to better meet our mission and values while serving our clients across the globe. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter, or contact us, so that we can discuss the appropriate alternatives available.

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Although this hasn't been an issue at The Planet Group, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at The Planet Group.

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