Clinical Safety Specialist

Job Description

The Clinical Safety Specialist is responsible for oversight of clinical research safety processes and systems.

This role coordinates among operational teams to manage and standardize safety event collection, review and reporting for applicable clinical trials and programs.Responsibilities

The Clinical Safety Specialist is responsible for oversight of clinical research safety processes and systems.

This role coordinates among operational teams to manage and standardize safety event collection, review and reporting for applicable clinical trials and programs.Qualifications

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

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