Safety Specialist

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 with senior management 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 the Medical Monitor, and CMO, the Safety Specialist liaises and establishes effective relationships with internal functional team members to implement and 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 with PV input 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 the Safety Database, CTMS, EDC and eTMF systems 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 research experience with 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 requirements for Medical and 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