Senior Safety Specialist

Position Description:

As the Sr. 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 processes.

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 area and disease states.

In collaboration 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 health care 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 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, etc., up to 25%.
• Ability to effectively 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 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 have regular and consistent attendance.
• Ability 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 interacts with others to obtain or relate information to diverse groups.
• Works independently with guidance or reliance on oral or written instructions and plans work schedules to meet goals.

Role maybe office or home based