Medical Safety Operations Manager/Senior Manager
700 Saginaw Drive Redwood City, CA 94063 US
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
- 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.
- 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.
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.