Clinical Safety Specialist - Hybrid/Remote
Thanks for your interest in the Clinical Safety Specialist - Hybrid/Remote position.
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REQUIRED QUALIFICATIONS:
Knowledge of:
- Clinical study development and execution pathway.
- Drug development cycle
- ICH Guidelines, GCP and FDA regulations.
Ability to:
- Communicate effectively in all situations with strong interpersonal and consultation skills
- Establish strong working relationships with internal and external clients, using diplomacy to address conflict and resolve solutions successfully
- Operate with a high degree of ethics
- Meet key deadlines and manage multiple projects and tasks simultaneously
- Write and communicate articulately and concisely
- Work proactively, take initiative and ownership and assess risk
- Problem-solve creatively
- Must exemplify our Be The Match Standards
Education and/or Experience:
- BSN, PA, APRN, NP, PharmD, or DO/MD with equivalent clinical experience
- Requires a minimum of Bachelor’s degree in a healthcare profession (e.g., nursing, pharmacy)
- Requires a minimum 2 years of experience in biotech medical/safety role
- Working knowledge of coding dictionaries (CTCAE, WHODrug, MedDRA) preferred
- Excellent oral and written communication skills
- Proven ability to provide comprehensive assessments of complex clinical scenarios
PREFERRED QUALIFICATIONS: (Additional qualifications that may make a person even more effective in the role, but are not required for consideration)
- Oncology experience
- Experience with pharmacovigilance systems
Be The Match offers regular, full-time employees medical, dental, vision, life and disability, accident/critical illness/hospital, well-being, legal, identity theft and pet benefits. Retirement, paid time off/holidays, leave and incentive plans are also offered to eligible employees. Please reference this link for more information: Be The Match Benefit Information