[Hiring] Safety Lead @Precision for Medicine

Role Description

Responsibilities will include but may not be limited to:

• Project specific teleconferences/meetings (i.e. Kick off meetings, internal study specific meetings, client governance meetings)
• Safety budget review and approval as needed
• Safety management plan development
• Oversight of serious adverse event (SAE, SUSARS) case management from intake to regulatory reporting
• Providing safety expertise in a timely manner upon request from team members, clients, and study site personnel

Essential functions of the job include but are not limited to:

• Interfacing with sponsors, vendors, and other internal team members in the area of safety/PV to assist in the design and implementation of safety collection tools, processes, and reporting systems
• Participate in the assessment and set-up of a safety database to capture SAE data
• QC of documents and safety reports when needed
• Preparation and/or review of project specific safety reporting plans and medical coding plans
• Preparation and/or review of safety training materials
• Review of safety related budget tasks and activities
• Develop and manage standard operating procedures and work instructions
• Serve as subject matter expert for department
• Provide ongoing training and mentorship for Safety Specialists
• Participate in audits and audit preparation, kick-off meetings, and investigator meetings
• Participate in the CAPA management process
• Participate in bid defenses for existing and potential clients
• Assist departmental management with resource management
• Assist departmental management with oversight
• Serve as project manager for safety standalone projects
• Lead departmental initiatives and cross-functional development activities
• Support the generation of SAE/AESI queries and tracking including oversight in the query resolution escalation efforts
• Provide input and review of responses to regulatory agency questions with regard to safety/pharmacovigilance activities
• Assist clients and/or other departmental staff with safety-related reviews and other services

Qualifications

• Minimum Required:
• BA/BS degree
• 10+ years clinical safety experience
• 5+ years Pharmacovigilance (PV) experience
• Other Requirements:
• Health care professional
• Hands on experience with global safety database(s), SAE case processing, and safety reports generation
• Working knowledge of MedDRA and WHODrug
• Working knowledge of FDA safety regulations, ICH guidelines, and Global regulations
• Demonstrated knowledge of relevant regulatory agency(s) guidelines governing both Safety reporting and processing for clinical trial environments
• Demonstrated knowledge of supporting internal audits, inspection readiness and regulatory agency(s) inspection support for clinical trials including BLA or NDA approval inspections
• Excellent communication and analytical skills (written and oral)
• Excellent judgment and ability to communicate complex clinical issues in a scientifically sound and understandable way
• Ability to work in a fast-paced, innovative environment while remaining flexible, proactive, resourceful, and efficient
• Preferred:
• Nursing or pharmacy degree
• Industry experience in CRO or pharmaceutical company
• Project management experience

Company Description