Job Title: Drug Safety Consultant
Location: Remote
Job Summary: We are seeking a skilled professional to manage pharmacovigilance activities critical to the safety of clinical development programs. Our team empowers safe, compliant drug development through rigorous signal detection, safety data analysis, and cross-functional collaboration.
Responsibilities:
- Support and/or lead the signal management process, including detection, tracking, documentation, and evaluation of safety data from multiple sources.
- Manage literature review and oversee responses to safety inquiries from regulatory authorities in collaboration with cross-functional teams.
- Lead or contribute to the strategy, review, and finalization of aggregate safety reports such as PSURs, DSURs, and Risk Management Plans (RMPs).
- Oversee day-to-day safety operations and safety management plans for assigned clinical trials, ensuring alignment with safety strategies and communications.
Required:
- Minimum 7 years of experience in pharmacovigilance, including aggregate safety reports and safety signal management.
- Bachelor’s degree in biologic or natural science, or health case discipline.
- Knowledge of MedDRA terminology and its application.
- Strong analytical and problem-solving skills with advanced MS Excel capabilities.
About SSI People: With over 26 years of industry experience, SSi People has built its reputation and expertise on putting people first. Everything we do works toward delivering exceptional experience for our consultants, our clients, and our internal team. Through a genuine commitment to people in everything we do. We have developed refined processes and a stellar internal team to deliver talent quickly. More importantly, we focus on building long-term relationships, not transactions. Putting people first is just what we do well.
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