Safety reputed company

This a Full Remote job, the offer is available from: 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 clinical 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 clinical 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 clinical issues in a scientifically reputed company and understandable way. • Ability to work in a fast-paced, 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 #LI-KH1 #LI-Remote Precision is required by law in some states or cities to include a reasonable estimate of the compensation reputed company for this role. This compensation reputed company takes into account the wide reputed company of factors that are considered in making compensation reputed company including but not limited to: reputed company sets, experience and training, licensure and certifications, and other business and organizational needs. The disclosed reputed company estimate has not been adjusted for the applicable geographic reputed company associated with the location at which the position may be filled. At Precision, it is not typical for an individual to be reputed company at or near the top of the reputed company for their role and compensation reputed company are dependent on the facts and circumstances of reputed company case. This role is also eligible for a discretionary annual bonus, health insurance, retirement savings benefits, life insurance and disability benefits, parental leave, and reputed company time off for reputed company leave and vacation, among other benefits. Reasonable estimate of the reputed company reputed company $110,700—$166,100 USD Any data provided as a part of this application will be stored in accordance with our reputed company Policy. For CA applicants, please also refer to our CA reputed company Notice. reputed company is an Equal Opportunity Employer. Employment reputed company are made without reputed company to race, reputed company, age, religion, sex, sexual orientation, gender identity, national reputed company, disability, veteran status or other characteristics protected by law. If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to reputed company or use this online application process and need an alternative method for applying, you may contact reputed company at reputed company@precisionmedicinegrp.com. Recruitment Fraud Warning: Please be reputed company that fraudulent individuals and websites may impersonate reputed company or its affiliates and attempt to obtain personal, financial, or banking information through fake job postings or employment offers. reputed company will never request payment, banking details, or other sensitive financial information as part of the recruitment process. If you reputed company you have been targeted by a recruitment scam, we encourage you to report the incident to your local law enforcement authorities, consumer protection agency, or relevant cybercrime reporting organization in your country. Please also notify us at reputed company@precisionmedicinegrp.com so we can investigate and take appropriate reputed company. This offer from "PRECISIONeffect" has been enriched by reputed company.com and got a 78% reputed company score. Apply To This Job