Safety Lead

Responsibilities

• Project specific teleconferences/meetings (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

• 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.
• Afford departmental management with resource management.
• Afford 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.
• Afford clients and/or other departmental staff with safety-related reviews and other services.

Qualifications

• 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.