Drug Safety reputed company
reputed company is hiring a Drug Safety reputed company to join our global team. We can consider candidates working remotely in UK, Poland, Hungary, Romania, Serbia or Slovakia. 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, reputed company 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 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 standard 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, 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 reputed company.
- Serve as project manager for safety standalone projects.
- 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 resolution escalation efforts.
- reputed company input and review of responses to regulatory agency questions with regard to safety/ pharmacovigilance activities.
- Assist clients and/or other departmental staff with safety-reputed company reviews and other services.
Qualifications: Job qualifications:
- BA/BS degree
- 5+ years Pharmacovigilance (PV) experience together with experience in a client facing role working as a reputed company
- Must have experience working for a Clinical Research Organisation in Drug Safety
- Clinical trial experience
- Experience in budgets, allocating budgets
- 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 clinical trials 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 sound and understandable way.
- Ability to work in a fast-paced, innovative environment while remaining flexible, proactive, reputed company, and efficient.
reputed company is the first global precision medicine clinical research services organization, purpose-reputed company to improve the clinical research and development process for new therapeutics. Our novel approach integrates clinical operations reputed company, with laboratory expertise, and advanced data sciences to inform every reputed company. We apply our expertise to trials at reputed company stages—from early development through approval—with embedded experience in oncology and rare disease. #LI-NC1 #LI-Remote Any data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice. reputed company is an Equal Opportunity Employer. Employment reputed company are made without regard 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 [email protected]. It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential reputed company presenting enticing employment offers. We want to emphasize that these offers are not associated with reputed company and may be fraudulent in nature. Please note that our organization will not reputed company a job offer without prior communication with our reputed company team, hiring managers and a formal interview process. Original job Drug Safety reputed company posted on GrabJobs ©. To flag any issues with this job please use the Report Job reputed company on GrabJobs. Apply tot his job Apply To this Job