Manager Drug Safety

Remote Drug Safety Opportunity!
This Jobot Job is hosted by: Audrey Block
Are you a fit? Easy Apply now by clicking the "Apply Now" button and sending us your resume.
Salary: $95 - $130 per hour

A bit about us:

We are a small biotech company working in the oncology space. We are looking for a part time Drug Safety manager to join our 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 role. Please see the details below!
Responsibilities:

• Reconciliation activities with all data sources providing safety information - Business Partners (BMS), IIST/Cooperative Groups (CCTG) and Internal Stakeholders to ensure compliance
• 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
• 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
• Act as record management coordinator for the Drug Safety Team
• 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)
• 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.
• Manage the process for identifying, evaluating, selecting and managing outsourcing vendors involved in safety data activities including CROs, call centers, safety database vendors.
• Oversee Drug Safety operations, including case processing, signal detection, and aggregate safety reports
• Collaborate with cross-functional teams, including clinical operations and biostatistics, to ensure safety data is accurately reported
• Manage CRO relationships and ensure timely delivery of safety data
• Ensure all safety-related activities are conducted in accordance with company policies and procedures

Qualifications:

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

If you are a highly motivated and experienced safety candidate, we encourage you to apply for this exciting opportunity!
Interested in hearing more? Easy Apply now by clicking the "Apply Now" button.