Principal Safety Specialist - EMEA-151029
PPD is a leading global contract research organization (CRO) providing comprehensive, integrated drug development, laboratory and lifecycle management services. Our clients and partners include pharmaceutical, biotechnology, medical device, academic and government organizations. With offices in 47 countries and approximately 20,000 professionals worldwide, PPD applies innovative technologies, therapeutic expertise and a firm commitment to quality to help clients and partners bend the cost and time curve of drug development to deliver life-changing therapies that improve health. The Principal Safety Specialist is responsible for coordinating and performing adverse event data entry, coding and assessment of adverse events, case review, follow up with reporter and/or associated HCP, tracking of reports, regulatory reporting activities and providing training, mentoring and work direction to more junior level staff. S/he participates in candidate interviews and assists in the development and review of procedural documents. The Principal Safety Specialist must maintain knowledge and understanding of PPD and client-provided SOPs and current FDA regulations and resolve complex issues through in-depth evaluation of various factors. S/he must effectively interface with project team members, client contacts and adverse event reporters and often serve as project lead to disseminate information to team members. Main Responsibilities:
- Works Independently to oversee day to day PVG activities. May participate in on-call duties for Specific projects to ensure 24 hour coverage for intake of cases from investigative sites
- Functions in a lead role. Exercises independent judgement to troubleshoot and resolve project issues and to identify areas for improvement. Serves as primary point of contact in the absence of the manager
- Mentors less experienced staff.
- Reviews regulatory/pharmacovigilance publications and information sources to keep updated on current regulations, practices, procedures and proposals. Maintains medical understanding of applicable therapeutic area and disease states.
- Participates in/lead departmental initiatives; Serves as a subject matter expert in designated area.
- Responsible for routine project implementation and coordination (e.g. Clinical Trials, Endpoint Assessment Committee/Data Safety Monitoring Committee), including presentations at client/investigator meetings, and review of metrics and budget considerations.
- Bachelor’s degree in Nursing, Medical Technology or Pharmacy
- Five (5) years of pharmacovigilance experience
- Two (2) years of experience working in a healthcare setting (e.g., hospital, clinic, laboratory, pharmacy)
- Or equivalent combination of education, training, and experience that provides the individual with the required knowledge, skills, and abilities to perform the job
- Excellent written and verbal communications skills
- Good Microsoft Word and Excel skills; good understanding of safety database functionality
- Strong working knowledge of procedural documents
- Strong working knowledge of applicable US and ROW regulatory requirements
- Ability to identify and set priorities and effectively perform a variety of tasks simultaneously, including those with set deadlines
- Strong attention to detail and accuracy with orientation toward careful and meticulous work
- Ability to maintain a positive attitude
- Ability to act as a liaison and communicate respectfully and diplomatically with all clients, management, project team members, and other internal staff members
- Ability to work effectively within a team to attain a shared goal
- Demonstrates initiative on the individual and team level
- Ability to maintain focus while working within strict timelines
- Ability to effectively delegate tasks and ensure successful completion
- Strong critical thinking and problem solving skills
- Ability to gain clear agreement and commitment from others through persuasion and influence
- Ability to coordinate, manage and motivate a team
- Licensure as a Nurse, Pharmacist or Medical Technologist
- Safety database experience
- Excellent knowledge of departmental procedural documents