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Drug Safety Associate I for Clinical Trials
3 months ago
Company Overview:
Everest Clinical Research Services Inc. is a comprehensive contract research organization (CRO) that offers a wide array of expertise-driven clinical research services to global pharmaceutical, biotechnology, and medical device sectors. We collaborate with some of the most renowned companies and are involved with many of the most innovative drugs, biologics, and medical devices currently under development.
Established as an independent CRO in 2004, Everest has built a robust foundation as a center of excellence in statistical and data management. Leveraging this foundation, we have successfully evolved into a full-service CRO. Our headquarters are situated in the Greater Toronto Area, with additional locations in the Greater New York City Area, China, and Taiwan.
Known for our commitment to high-quality deliverables, exceptional customer service, and adaptability to client needs, Everest is a dynamic organization with a strong entrepreneurial spirit, experiencing remarkable growth and success.
Position Overview:
To support our ongoing success in the clinical research arena, we are seeking a dedicated, skilled, and client-oriented individual to fulfill the role of Clinical Trial Drug Safety Associate I. This position can be performed on-site or remotely in accordance with our flexible work policy.
Key Responsibilities:
- Conduct pharmacovigilance (PV) and medical device vigilance (MDV) activities for clients, ensuring adherence to company standard operating procedures (SOPs), operational practices, and regulatory guidelines.
- Facilitate training on study-related materials pertinent to the processing of Individual Case Safety Reports (ICSRs) for clinical trials, including the study protocol and Safety Management Plan (SMP).
- Execute PV activities promptly, aligning with regulatory and sponsor reporting obligations.
- Act as the Lead Safety Associate for designated trials, ensuring compliance with all pharmacovigilance requirements.
- Perform quality control (QC) reviews of case processing conducted by other PV personnel, ensuring that all documentation is complete and adheres to regulatory standards.
- Generate regulatory report forms for reportable events for submission to regulatory authorities and relevant boards.
- Engage in the design of SAE report forms to capture safety data in clinical trials.
- Review and occasionally draft study-specific SMPs.
- Reconcile safety data between clinical and safety databases.
- Participate in user acceptance testing (UAT) of safety database builds to validate study configurations.
- Contribute to the preparation and review of additional regulatory documents as necessary.
- Provide coverage for case processing during weekends and holidays on a rotating basis.
- Ensure compliance with all applicable regulations and timelines for safety case processing and reporting.
- Stay updated with industry best practices in pharmacovigilance and medical device vigilance.
- Manage deliverables and timelines in accordance with clinical trial project teams' requirements.
Qualifications:
- Bachelor's or Master's degree in Clinical, Medical, or Life Sciences with relevant experience.
- A minimum of two years of experience in drug safety within a pharmaceutical or clinical research setting.
- Experience across Phase I to Phase IV clinical trials with knowledge of drug and medical device safety regulations.
- Familiarity with safety case processing of serious adverse events (SAEs).
- Proficiency in clinical data capture and management systems is preferred.
- Strong verbal and written communication skills, with the ability to comprehend and summarize medical terminology.
- Excellent organizational skills, capable of adapting to changing priorities and managing multiple assignments.
- Ability to maintain confidentiality regarding clinical and proprietary data.
- Detail-oriented with a focus on customer service and quality.
- Strong interpersonal and teamwork capabilities.
- Proficient in MS Office applications.
