Safety Specialist

Catalyst Clinical Research provides customizable solutions to the biopharmaceutical and biotechnology industries through Catalyst Oncology , a full-service oncology CRO,andmulti-therapeutic global functional and CRO services through Catalyst Flex . The company\’s customer-centric flexible service model, innovative technology, expert team members, and global presence advance clinical studies. Visit CatalystCR.com .

As a Safety Specialist you are a key member of the Flex Operations, Safety Team and coordinates and manages contracted safety responsibilities for one or more programs, including staffing, training, and procedural compliance.This person works withseniormanagement to develop consistent internal processes and ensures compliance with established processes.

The Safety Specialist proactively liaises with the Project Manager and clients to ensure optimal performance and utilization of the safety project team. They manage all aspects of multiple projects, ensuring that contractual, procedural, and regulatory requirements are met. This may include serving as back-up for project coverage when needed.The Safety Specialist maintains medical understanding of applicable therapeutic area and disease states. In collaboration with theMedical Monitor, and CMO,the Safety Specialist liaises and establishes effective relationships with internal functional team members to implementand manage projects.

Position Responsibilities:

• Assist with the implementation of appropriate reporting processes and coordinate with staff, third party and/or consultants to complete reports within required regulatory timeframes.
• Assist in the onboarding and training of Pharmacovigilance (PV) Safety Staff.
• Support Project Management team representatives withPVinput for meetings and financial matters.
• Assist with revenue recognition and profitability review processes (in collaboration with Director of Safety).
• Responsible for the completion of Quality Events (QE) and/ or CAPA in response to internally identified system/process weaknesses and/or customer complaints related to PV.
• Accountable for providing input on the financial management of the medical and safety portion of study budgets.
• Support implementation activities to configure theSafety Database,CTMS, EDC andeTMFsystems and to draft SOPs describing core processes.
• Other responsibilities and ad hoc projects as required.

Education: Healthcare or life science degree; with optional licensure as a health care professional (MD, RN, RRT, MLT).

Experience: 2 years of clinical researchexperiencewith a CRO

Required Skills:

• Knowledge of the drug development process and FDA regulations, ICH GCP guidelines, and their application to clinical trials.
• Knowledge of global regulatory reporting requirements for safety updates, Adverse Event reporting and other requirementsforMedicaland Safety submissions.
• Ability and willingness to travel to investigator meetings, investigative sites and bid defense meetings, etc., up to 25%.
• Ability to effectively analyze project-specific data/systems to ensure accuracy and efficiency.
• Proficient with Microsoft Office Suite.
• Excellent written and oral communication skills.
• Excellent presentation skills.
• Strong organizational, problem-solving, and analytical skills.
• Ability to manage priorities and workflow.
• Versatility, flexibility, and a willingness to work within constantly changing priorities.
• Proven ability to handle multiple projects and meet deadlines.
• Strong interpersonal skills.
• Ability to deal effectively with a diversity of individuals at all organizational levels.
• Commitment to excellence and high standards.
• Creative, flexible, and innovative team player.
• Ability to work independently and as a member of various teams and committees.
• Good judgement with the ability to make timely and sound decisions

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