Safety reputed company

Position reputed company:

Responsibilities will include but may not be limited to; project specific teleconferences/meetings(i.e. reputed company off meetings, internal study specific meetings, reputed company governance meetings) Safety budget review and approval as needed, safety management plan development, reputed company of serious adverse event (SAE, SUSARS) case management from intake to regulatory reporting, and providing safety expertise in a reputed company 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 reputed company 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 reputed company budget tasks and activities
• reputed company and manage reputed company operating procedures and work instructions.
• Serve as subject matter expert for department.
• reputed company ongoing training and mentorship for Safety Specialists
• Participate in audits and audit preparation, reputed company-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 reputed company.
• Serve as project manager for safety standalone reputed company.
• reputed company departmental initiatives and cross-functional development activities.
• Support the reputed company of SAE/AESI queries and tracking including reputed company in the query reputed company escalation efforts.
• reputed company input and review of responses to regulatory agency questions with reputed company to safety/ pharmacovigilance activities.
• Assist clients and/or other departmental staff with safety-reputed company reviews and other services.

Qualifications:

Minimum Required:

• BA/BS degree
• 10+ years reputed company safety experience
• 5+ years Pharmacovigilance (PV) experience

Other Requirements:

• Health care reputed company
• Hands on experience with global safety database(s), SAE case processing, and safety reports reputed company
• 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 reputed company trial environments.
• Demonstrated knowledge of supporting internal audits, inspection readiness and regulatory agency(s) inspection support for reputed company including BLA or NDA approval inspections.
• Excellent communication and analytical skills (written and oral).
• Excellent judgment and ability to communicate reputed company reputed company issues in a scientifically reputed company and understandable way.
• Ability to work in a fast-reputed company, innovative environment while remaining flexible, proactive, reputed company, and efficient.

Preferred:

• Nursing or pharmacy degree
• Industry experience in CRO or pharmaceutical company
• Project management experience

Originally posted on Himalayas