Join a leading global organization dedicated to advancing healthcare through pharmacovigilance (PV) and clinical research. Our company specializes in drug safety monitoring, ensuring compliance with regulatory standards while improving patient outcomes. With a strong focus on innovation and collaboration, we provide a dynamic work environment for professionals looking to grow in the pharmaceutical and life sciences industry.
Job Description
We are seeking an experienced Safety Specialist (Pharmacovigilance) to manage day-to-day PV activities in a highly regulated environment. This role involves monitoring, assessing, and reporting adverse events (AEs) while ensuring compliance with global safety regulations.
Key Responsibilities:
- Perform pharmacovigilance activities including case processing, data entry, coding, and assessment of adverse events.
- Review and validate cases for accuracy, consistency, and regulatory compliance.
- Prepare and submit regulatory safety reports (e.g., SUSARs, PSURs).
- Collaborate with project teams, clients, investigators, and third-party vendors.
- Assist in audits, kick-off meetings, and investigator meetings.
- Stay updated on PV regulations, guidelines, and industry best practices.
- Mentor junior team members and support process improvements.
Requirements:
- Education: Bachelor’s degree or equivalent in life sciences/pharmacy/related field.
- Experience: Minimum 4+ years in PV case processing (Clinical Trial & Post-Marketing Surveillance cases).
- Technical Skills: Proficiency in Argus Safety Database and Microsoft Office (Word, Excel, Outlook).
- Soft Skills: Strong attention to detail, problem-solving, and communication skills.
- Regulatory Knowledge: Understanding of ICH-GCP, FDA, EMA, and other PV guidelines.
Why Apply?
- Fully remote work opportunity.
- Competitive salary and benefits.
- Career growth in a global pharmacovigilance setting.
- Work with industry-leading safety databases and processes.
