Contract Role-Manager Drug Safety

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Job details

Remote-Part Time Drug Safety Opportunity!

This Jobot Job is hosted by Audrey Block

Are you a fit? Easy Apply now by clicking the "Apply" button and sending us your resume.

Salary $95 - $115 per hour

A Bit About Us

We are a small biotech company headquartered in San Diego, CA working in the oncology space. We are looking for a part time (10 hours a week to start), drug safety manager to help set up our internal safety team. Please contact me for more details!

Why join us?

Opportunity for growth

Working in the oncology space with exciting science

Strong company culture

Flexible work schedule

100% remote work

Job Details

We are seeking a highly motivated and experienced Drug Safety candidate (flexible on experience) to join our team and set up the internal safety aspects. This is a part time consultant role, that will require about 10 hours a week!

Responsibilities

• Ensure the accurate and timely completion and reporting of periodic and expedited safety reports, in compliance with internal timelines and timelines set by regulatory authorities. Follow up queries and clarifications with partners (CRO, IIST, Partners)
• Accurately capture data of adverse event reports on the safety database in accordance with global and local regulatory requirements and ensure consistency between EDC data and Safety database
• Oversee drug safety operations, including case processing, signal detection, and aggregate safety reports
• Manage the process for identifying, evaluating, selecting and managing outsourcing vendors involved in safety data activities including CROs, call centers, safety database vendors.
• Manage CRO relationships and ensure timely delivery of safety data
• Review and reconcile activities associated with Pharmacovigilance Agreements and eventually start helping us develop our own internal SOP’s. Assist in the negotiation of safety exchange agreements with license partners in support of process definition, monitoring and other roles ensuring operational timelines can be met
• Ensure all safety-related activities are conducted in accordance with company policies and procedures
• Act as record management coordinator for the Drug Safety Team
• Reconciliation activities with all data sources providing safety information - Business Partners (BMS), IIST/Cooperative Groups (CCTG) and Internal Stakeholders to ensure compliance
• Assist in the production and validation of appropriate safety data output from the safety database for required safety deliverables including generation of IB and DSUR.
• Collaborate with cross-functional teams, including clinical operations and biostatistics, to ensure safety data is accurately reported

Qualifications

• Strong understanding of regulatory requirements, including FDA guidelines and REMs/RMPs
• Knowledge of case processing and aggregate safety reporting
• Experience with safety data management and signal detection
• Excellent communication and interpersonal skills
• Familiarity with safety databases, such as Argus
• Experience in oncology and solid tumors preferred
• Ability to work in a fast-paced environment and manage multiple projects simultaneously
• 3+ years of experience in drug safety and pharmacovigilance
• Strong attention to detail and ability to analyze complex data
• Experience in preparing and presenting safety reports to senior management and regulatory agencies.
• Experience in project management and clinical operations
• Bachelor's degree in a scientific field; advanced degree preferred

If you are a highly motivated and experienced Drug Safety candidate, we encourage you to apply for this exciting opportunity!

Interested in hearing more? Easy Apply now by clicking the "Apply" button.

Want to learn more about this role and Jobot?

Click our Jobot logo and follow our LinkedIn page!