What are the responsibilities and job description for the Senior Safety Scientist position at ClinLab Staffing?
Sr/Safety Scientist, Drug Safety &Pharmacovigilance
Responsibilities (including, but not limited to):
- Safety Data Monitoring: Continuously monitor safety data from clinical trials to identify potential safety signals
- Safety Management Team: Organize meetings, summarize and analyze safety data and prepare meeting minutes
- Adverse Event Reporting: Ensure the timely collection, analysis, and reporting of adverse events in accordance with regulatory requirements and company policies. Track and monitor all SAEs and SUSARs
- Risk Management: Develop and implement risk management plans to mitigate potential safety risks
- Regulatory Compliance: Ensure compliance with all relevant regulatory guidelines, including FDA, EMA, and ICH guidelines
- Safety Documentation: Prepare and review safety-related documents, including Safety Management Plan, Study Protocols and Amendments, Informed Consent Forms, Investigator Brochure, DSUR/PSUR, CTD Module 2.5 & 2.7.4, Risk Management Plan and Company Core Data Sheet
- Cross-Functional Collaboration: Work closely with clinical operations, clinical development, regulatory affairs, and other departments, including the PV vendor, to ensure the safety of clinical trial participants
- Safety Signal Detection: Oversee the use of statistical methods and data analysis tools to detect and evaluate safety signals
- Literature Surveillance: Oversee the PV vendor literature surveillance plan and operations
- Training and Education: Provide training and support to clinical trial staff on safety reporting and regulatory requirements
- Perform other duties as assigned
Requirements
- Requires a Bachelor’s degree in a scientific discipline (e.g., biology, pharmacy, nursing) with 10 years experience OR Advanced degree (e.g., Master’s, PhD) preferred) with 7 years of clinical safety or pharmacovigilance.
- Strong understanding of clinical trial processes, regulatory requirements, and safety reporting guidelines
- Thorough knowledge of relevant EU GVP, FDA and ICH guidelines, including Good Clinical Practices (GCP) guidelines
- Knowledge of MedDRA and WHO Drug Dictionary terminology and its application as well as experience with common safety database systems (Argus/ArisG/Veeva Safety)
- Development and review of SOPs and Work Instructions
- Excellent organizational skills and demonstrated ability to navigate in a fast-paced environment with changing priorities
- Excellent verbal and written communication skills including the ability to present to both internal and external partners
- Attention to detail and high level of accuracy
- Ability to work both independently and as part of a team
- Strong problem-solving skills and sound decision-making under pressure
- The salary range for this position is commensurate with experience
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