Clinical Safety Scientist

Clinical Safety Scientist - Contract - Cambridge MA

Shape your future with the freedom to work where you thrive! Join our client in this Clinical Safety hybrid role that fits around your life.

Primary Responsibilities:

This position will supply strong knowledge in safety evaluation and risk management for key assets in clinical development and post-marketing settings. In this role, you will ensure the thorough review and interpretation of safety data, manage safety issues, and contribute to global pharmacovigilance efforts to ensure patient safety.

Skills & Requirements:

• Strong proficiency in pharmacovigilance, drug safety, and risk management in both clinical development and post-marketing settings.
• Strong analytical skills for evaluating clinical data, literature, and safety information.
• Knowledge of international pharmacovigilance requirements, including ICH guidelines, GVP modules, and CIOMS initiatives.
• Proven ability to make informed decisions and solve complex problems effectively.
• Experience working in large matrix organizations and leading cross-functional teams.
• Excellent communication and influencing skills, with the ability to present confidently to senior staff and external stakeholders.
• Relevant degree qualification (e.g., PharmD, PhD, MD).
• Experience in vaccine safety is highly desirable.

The Clinical Safety Scientist's responsibilities will be:

• Conduct safety evaluations and risk management for assigned global assets.
• Review and interpret clinical and post-marketing safety data to identify and address safety concerns.
• Develop strategies for pharmacovigilance and risk management planning.
• Lead the safety component of global regulatory submissions.
• Facilitate safety governance and cross-functional team operations to address product safety issues.
• Ensure implementation of risk-reduction strategies in clinical study protocols and product labeling.
• Participate in cross-functional initiatives to improve adherence to regulations, data standards, and quality.
• Author and update standard operating procedures (SOPs) to ensure compliance with policies and regulations.
• Present safety recommendations and issues to senior governance committees and external stakeholders, including regulatory authorities.
• Build strong working relationships and provide leadership on safety matters within a matrix team environment.
• Coach and mentor team members on safety-related processes and best practices.

Compensation:

• $80 to $100 per hour

If you are having difficulty in applying or if you have any questions, please contact Jackie Cerchio at j.cerchio@proclinical.com

If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists please request a call back at the top of this page.

Proclinical is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Proclinical is acting as an Employment Agency in relation to this vacancy.

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