Senior Safety Scientist

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