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Medical Safety Operations Associate

Redwood City, CA 94063

Posted: 05/30/2023 Employment Type: Contract Job Category: Pharmacovigilance Job Number: 561132 Is job remote?: No Country: United States

Job Description


The Opportunity:
Market Rate

The Medical Safety Operations Associate will assist with day-to-day operational aspects of management and oversight of the Pharmacovigilance Contract Research Organization (PV CRO) and the execution of safety reporting in clinical studies.

Specifically, you will be responsible for: 
  • Assisting with the oversight of the PV CRO performing case management and study support activities.
  • Assisting with the management of the PV CRO to ensure compliance with required timelines, that potential issues are being communicated and resolution is achieved in a timely manner.
  • Providing vendors with relevant clinical study documents and updates.
  • Coordinating the review of medical safety study plans and compliance metrics reports.
  • Participating in SAE follow-up query management and SAE reconciliation in collaboration with other functions in the study team.
  • Coordinating the review of the PV CRO budget, invoices, and monthly compliance reports.
  • Tracking and maintaining well-organized department files, including listings and trackers.
  • Assisting in the oversight of eTMF filing of case files by PV CROs.
  • Maintaining PV CRO distribution contact lists.
  • Aiding in preparing meeting materials, scheduling meetings, developing agendas, and tracking meeting minutes.
  • Performing administrative tasks to support Medical Safety team members, as needed.
  • Supporting medical safety team in other PV activities appropriate to experience and expertise.
Required Experience, Skills, and Education:
  • Bachelor’s degree in natural or health sciences or a minimum of 2 years of relevant industry experience in lieu
  • Experience working with CROs/vendors and management of external resources is preferred.
  • Opportunities for successful candidates will be available to learn about safety reporting in global clinical trials and other aspects of drug safety.
  • Reliable, self-motivated, focused, positive attitude, proactive and solution-oriented problem solver, able to adapt to changes in priorities, structures, tasks, and goals.
  • 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.
  • Able to create and sustain strong working relationships with remote staff using video conferencing and instant messaging, as needed.
  • Exercise discretion regarding highly confidential internal and external communications.
  • Software Knowledge: MS Office 365 (Outlook, Word, PowerPoint, Excel), Adobe Acrobat.

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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