Senior Safety Specialist

Catalyst Clinical Research, LLC; United States; Remote; USD 75,000 - 120,000; Full time

Job summary

Catalyst Clinical Research, a leader in biopharmaceutical solutions, seeks a Senior Safety Specialist to oversee pharmacovigilance responsibilities. The ideal candidate will manage project safety compliance, work with internal teams, and facilitate client communication. This role requires a strong background in drug development, excellent communication skills, and the ability to navigate regulatory requirements.

Qualifications

• At least 5 years in CRO or pharmaceutical with 3 years in pharmacovigilance.
• Experience with lifecycle safety and aggregate report preparation a plus.
• Optional licensure as healthcare professional (MD, RN, RRT, MLT).

Responsibilities

• Coordinate safety responsibilities for programs including staffing and training.
• Liaise with Project Manager and clients to ensure project performance.
• Maintain medical understanding of applicable therapeutic areas.

Skills

Knowledge of drug development process

Fluent English

Interpersonal skills

Attention to detail

Critical thinking

Analytical skills

Problem-solving capabilities

Education

Healthcare or life science degree

Tools

Computer applications knowledge

Job description

Catalyst Clinical Research provides customizable solutions to the biopharmaceutical and biotechnology industries through Catalyst Oncology, a full-service oncology CRO, and multi-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.

Position Description:

As the Senior Safety Specialist (SS), you will be a key member of the Pharmacovigilance (PV) organization, responsible for coordinating and managing contracted safety responsibilities for one or more programs, including staffing, training, and procedural compliance. You will work with senior management to develop consistent internal processes and ensure compliance with established procedures.

You will proactively liaise with the Project Manager and clients to ensure optimal performance and utilization of the safety project team. You will 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. You will maintain medical understanding of applicable therapeutic areas and disease states.

In collaboration with the Medical Monitor (MM) and CMO, you will liaise and establish effective relationships with internal functional team members to implement and manage projects.

Position Qualifications:

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

Experience: At least 5 years of experience working in a CRO or pharmaceutical company and 3 years of pharmacovigilance experience. Preferred is experience with lifecycle safety, including preparing aggregate reports and literature surveillance.

Required Skills:

• Strong knowledge of the drug development process and FDA regulations, ICH GCP guidelines, and their application to clinical trials and marketed products.
• Knowledge and experience with global regulatory reporting requirements for safety updates, Adverse Event reporting, and other requirements for Medical and Safety submissions.
• Experience with Oncology treatment paths and Standards of Care.
• Excellent written, oral communication, and presentation skills.
• Excellent interpersonal and organizational skills with demonstrated attention to detail.
• Ability to read, write, and speak fluent English.
• Ability to build positive, productive client and team member relationships.
• Demonstrated management and problem-solving capabilities; strong critical thinking and analytical skills.
• Good computer skills with a good working knowledge of a range of computer applications.
• Ability to meet deadlines, multitask, and prioritize based on project needs.
• Ability to make sound decisions based on available information.
• Ability to work both in a team and independently.
• Ability to lead team meetings and teleconferences.
• Ability and willingness to travel to investigator meetings, investigative sites, and bid defense meetings, up to 25%.
• Ability to analyze project-specific data/systems to ensure accuracy and efficiency.
• Ability to act as a liaison and communicate respectfully and diplomatically with all clients, management, project team members, and other internal staff.
• Strong attention to detail and accuracy with an orientation toward careful and meticulous work.
• Flexibility to re-prioritize workload to meet changing project and regulatory timelines.
• Ability to perform under stress and multi-task.
• Ability to maintain regular and consistent attendance.
• Effective communication skills to convey information clearly and listen actively.
• Ability to interact with diverse groups to obtain or share information.
• Work independently with guidance, planning work schedules to meet goals.