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

• Regularly review adverse events for consistency, clarity, and completeness; review adverse event listings for trends and anomalies; perform continuous quality review of adverse event data
• Review and process Adverse Events of Special Interest (AESIs) and Serious Adverse Events (SAEs) per protocol-specific requirements: provide first line evaluation of AESIs and SAEs; evaluate AESI and SAE data for completeness; coordinate with sites to obtain clarification or additional supporting data; review de-identified source documentation; raise and manage safety queries in the clinical database; triage AESI and SAE reviews to the protocol medical monitor or other team members, as appropriate; follow-up on AESIs and SAE outcomes
• Draft or write safety narratives for adverse events per protocol-specific requirements and for Data and Safety Monitoring Board/Committee (DSMB/DSMC) reports, regulatory submissions, and final study reports as required
• Collaborates for training and onboarding of medical monitors
• Liaison with in-house medical team for support and ongoing best practices for safety event review
• Coordinate safety review activities with study medical monitor, project manager, clinical monitoring, and data management
• Collaborate with data management and biostatistics for the development and dissemination of safety reports and listings
• Assist with processing of medical coding (e.g., MedDRA, WHODrug, CTCAE)
• Review protocol, safety plan and case report form development: advise on standardization of safety monitoring rules; advise on adverse event reporting workflows
• Communicate with protocol teams, Sponsors, Data and Safety Monitoring Board/Committee (DSMB/DSMC), Endpoint Committee Reviewers (ECRs), and other stakeholders regarding safety events and data

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

About The TeamNMDP 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: NMDP Benefit Information