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Senior Safety Specialist

Catalyst Clinical Research, LLC

United Kingdom

Remote

GBP 50,000 - 70,000

Full time

3 days ago
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Job summary

Catalyst Clinical Research is seeking a Senior Safety Specialist to oversee safety project management and ensure compliance within their Pharmacovigilance organization. This role involves managing multiple projects, coordinating with clients, and maintaining medical knowledge in relevant therapeutic areas. Candidates require a healthcare degree and substantial experience in the CRO or pharmaceutical sector, particularly in pharmacovigilance.

Qualifications

  • Minimum 5 years in CRO/pharmaceutical company; 3 years in pharmacovigilance.
  • Experience with lifecycle safety; preparing aggregate reports preferred.

Responsibilities

  • Coordinate and manage contracted safety responsibilities across programs.
  • Ensure compliance with contractual and regulatory requirements.
  • Liaise with Project Manager and clients for project performance.

Skills

Knowledge of drug development process
Knowledge of FDA regulations
Knowledge of oncology treatment paths
Excellent written communication
Excellent interpersonal skills
Problem-solving capabilities
Attention to detail
Ability to multitask

Education

Healthcare or life science degree

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 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 with 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.
  • Willingness to travel up to 25% for investigator meetings, investigative sites, and bid defense meetings.
  • Ability to analyze project-specific data/systems to ensure accuracy and efficiency.
  • Effective communication skills to liaise respectfully and diplomatically with clients, management, project team members, and internal staff.
  • Strong attention to detail and accuracy, with a focus on meticulous work.
  • Flexibility to re-prioritize workload to meet changing project and regulatory timelines.
  • Ability to perform under stress and handle multiple tasks.
  • Consistent attendance and punctuality.
  • Effective communication skills for conveying ideas clearly and listening actively.
  • Ability to work independently with guidance, planning work schedules to meet goals.
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