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:
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.
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