Position Summary:

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, and 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

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