Senior Safety Specialist

Summary

Join our Pharmacovigilance (PV) organization as a Sr. Safety Specialist! You will be a key member, coordinating and managing contracted safety responsibilities for one or more programs. Collaborate with senior management to develop internal processes and ensure compliance. Proactively liaise with project managers and clients for optimal performance. Manage all aspects of multiple projects, meeting contractual, procedural, and regulatory requirements. Maintain medical understanding of applicable therapeutic areas. Establish effective relationships with internal teams to implement and manage projects.

Requirements

• Possess a Healthcare or life science degree with PV experience
• Have at least 5 years of experience working in a CRO or pharmaceutical company and 3 years of pharmacovigilance experience
• Demonstrate strong knowledge of the drug development process and FDA regulations, ICH GCP guidelines, and their application to clinical trials and marketed products
• Possess knowledge and experience with global regulatory reporting requirements for safety updates, Adverse Event reporting and other requirements for Medical and Safety submissions
• Have experience with Oncology treatment paths and Standards of Care
• Possess excellent written, oral communication and presentation skills
• Possess excellent interpersonal and organizational skills with demonstrated attention to detail
• Be able to read, write and speak fluent English
• Be able to build positive, productive client and team member relationships
• Demonstrate management and problem-solving capabilities; strong critical thinking, and analytical skills
• Have good computer skills with good working knowledge of a range of computer applications
• Be able to meet deadlines, multitask, and prioritize based on project needs
• Be able to make sound decisions based on available information
• Be able to work both in a team and independently
• Be able to lead team meetings and teleconferences
• Be able and willing to travel to investigator meetings, investigative sites and bid defense meetings, etc., up to 25%
• Be able to effectively analyze project-specific data/systems to ensure accuracy and efficiency
• Be able to act as a liaison and communicate respectfully and diplomatically with all clients, management, project team members and other internal staff
• Demonstrate strong attention to detail and accuracy with orientation toward careful and meticulous work
• Have the flexibility to re-prioritize workload to meet changing project and regulatory timelines
• Be able to perform under stress and multi-task
• Be able to have regular and consistent attendance
• Be able to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences
• Frequently interact with others to obtain or relate information to diverse groups
• Work independently with guidance or reliance on oral or written instructions and plans work schedules to meet goals

Responsibilities

• Coordinate and manage contracted safety responsibilities for one or more programs, including staffing, training, and procedural compliance
• Work with senior management to develop consistent internal processes and ensure compliance with established processes
• Proactively liaise with the Project Manager and clients to ensure optimal performance and utilization of the safety project team
• Manage all aspects of multiple projects, ensuring that contractual, procedural, and regulatory requirements are met
• Serve as back-up for project coverage when needed
• Maintain medical understanding of applicable therapeutic area and disease states
• Liaise and establish effective relationships with internal functional team members to implement and manage projects

Preferred Qualifications

• Possess licensure as a health care professional (MD, RN, RRT, MLT)
• Have experience with lifecycle safety, including preparing aggregate reports and literature surveillance

Benefits

Role may be office or home based