Principal Pharmacovigilance Specialist (Biotechnology, Onsite)

Job summary

This position involves overseeing clinical safety for early development projects in inflammatory diseases, focusing on safety strategy and surveillance throughout clinical phases and regulatory submissions.

Qualifications

• Master's degree in Medicine (MD), Pharmacy, or Human Biology
• At least 7 years of experience in clinical safety or pharmacovigilance
• Proven track record in developing and executing safety strategies
• Strong skills in signal detection and benefit-risk evaluation
• Experience with regulatory submissions and safety reporting
• Familiarity with Risk Management Plans (RMP) and Risk Evaluation and Minimization Strategies (REMS); PhD or additional qualifications in Drug Development or Pharmacovigilance are advantageous

Responsibilities

• Act as the Patient Safety representative in cross-functional project teams
• Engage with regulatory authorities regarding safety matters
• Develop safety surveillance strategies for clinical trials
• Conduct signal detection activities to inform internal Safety Committee decisions
• Perform safety analyses and contribute to regulatory submission documents
• Prepare Risk Management Plans and related strategies

Skills

• High ethical standards and a strong quality mindset
• Collaborative and proactive approach to work
• Effective communication skills for building relationships with stakeholders

Education

• Master's degree in relevant fields; PhD or additional qualifications preferred

Tools

• Experience with safety surveillance systems and regulatory submission tools