What are the responsibilities and job description for the Safety Data Management Specialist position at Synterex?
Synterex, Inc. is a consortium of highly experienced clinical development professionals specializing in medical writing, submission publishing, and clinical science and operations support. Synterex offers remote or on-site services, with a focus on providing clear, concise, accurate, and fully compliant documentation, from early drug and device development through post-approval. Synterex is seeking an organized, motivated, and collaborative individual for our Safety Data Management Specialist.
As a Safety Data Management Specialist, you will be responsible for the review, preparation, and completion of reports of adverse drug experiences, to determine the safety profile for the client’s products and to meet regulatory requirements. You will also make a determination of local submission of individuals and, where appropriate, aggregate safety reports.
Contract length: 18 months
Location: 100% Onsite Role – Peapack, NJ
Must follow return to site policy
Essential Duties & Responsibilities:
- Responsible for the review, preparation, and completion of reports of adverse drug experiences to determine the safety profile for the client’s products and to meet regulatory requirements.
- Make a determination of local submissions or individuals and where appropriate aggregate safety reports.
- Carry out case processing activities.
- Review, rank, verify, process and document case-related information; validity, seriousness, special scenarios; timelines; accuracy and consistency. Process cases based on these assessments.
- Review case criteria to determine appropriate workflow for case processing.
- Assess case to distinguish those with complexities and/or specific issues and escalate appropriately.
- Write and edit case narrative.
- Determine and perform appropriate case follow-up, including generation of follow-up requests.
- Liaise with key partners, locally, and other stakeholders regarding safety data collection and data reconciliation.
- Develop and maintain expertise and knowledge for applicable corporate and global regulations, for guidelines, Standard Operating Procedures, for data entry conventions, and for search functions in the safety database.
- Determine reportability of scheduled reports, ensuring adherence to regulatory requirements.
- Consistently apply regulatory requirements and client’s policies.
- Participate, as appropriate, in local, internal, and external safety activities.
Requirements:
- Health care Professional or equivalent experience preferred.
- Ability to solve routine problems and to surface issues constructively.
- Ability to make basic decisions with an understanding of the consequences.
- Ability to achieve personal objectives while meeting departmental standard of performance.
- Ability to work under supervision in a matrix organization.
- Fluency in spoken and written English.
- Experience in case management and safety data management is preferred.
For further information or to apply, please reach out to careers@synterex.com.
Synterex provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.
