PPD® is a leading global contract research organization (CRO) that provides comprehensive drug development, laboratory, and lifecycle management services. Our clinical research team is at the forefront of accelerating the delivery of life-changing therapies to patients worldwide. With a strong commitment to scientific excellence and regulatory compliance, we support pharmaceutical, biotechnology, and medical device companies in bringing innovative treatments to market.
Job Description
We are seeking an experienced Sr Safety Specialist to join our Pharmacovigilance (PV) team. This role involves performing and overseeing day-to-day PV activities in a highly regulated environment with strict timelines. The ideal candidate will ensure the accurate collection, assessment, and reporting of safety data while collaborating with project teams, clients, investigators, and third-party vendors.
Key Responsibilities:
- Perform pharmacovigilance activities, including case processing, monitoring, and evaluation of safety data.
- Provide leadership and mentorship to junior team members.
- Assist in developing procedural documents and preparing for audits.
- Stay updated on global PV regulations and therapeutic area knowledge.
- Ensure quality and consistency in adverse event (AE) case reporting.
- Support clinical trial safety management, including Data Safety Monitoring Committee (DSMC) activities.
- Maintain compliance with regulatory requirements and company SOPs.
Qualifications & Experience:
- Education: Bachelor’s or Master’s degree in Life Sciences or Clinical Sciences.
- Experience: Minimum 3+ years in pharmacovigilance, case processing, or drug safety.
- Skills Required:
- Strong understanding of pathophysiology and disease processes.
- Proficiency in pharmacovigilance databases and Microsoft Office (Word, Excel, Outlook).
- Excellent critical thinking, problem-solving, and communication skills.
- Ability to manage multiple tasks under tight deadlines.
- Knowledge of global regulatory requirements (ICH-GCP, FDA, EMA).
Why Join PPD?
- Fully remote work with flexible scheduling.
- Opportunity to work on cutting-edge clinical trials and contribute to life-saving therapies.
- Collaborative and supportive team environment.
- Career growth and professional development opportunities.
