Principal Pharmacovigilance Specialist (Biotechnology, Onsite)

Job summary

This position focuses on clinical safety responsibilities for early development phase projects in inflammatory diseases, contributing to safety strategy and proactive surveillance across clinical programs. The role involves significant interaction with regulatory authorities and encompasses a wide range of responsibilities from early clinical phases to regulatory submissions.

Qualifications

• Master’s degree in Medicine (MD), Pharmacy, or Human Biology
• At least 7 years of experience in clinical safety or pharmacovigilance with a focus on safety surveillance
• Proven experience in developing and executing safety strategies throughout clinical development
• Strong skills in signal detection and benefit-risk evaluation to inform governance decisions
• Experience with aggregated safety analyses and contributions to regulatory submissions (NDA/MAA)
• Familiarity with Risk Management Plans (RMP) and/or Risk Evaluation and Minimization Strategies (REMS); a PhD or degree in Drug Development or Pharmacovigilance is a plus

Responsibilities

• Represent Patient Safety in cross-functional project teams and meetings with regulatory authorities
• Develop safety surveillance strategies for assigned projects and clinical trials
• Conduct signal detection activities to support internal Safety Committee evaluations
• Perform safety analyses and prepare aggregated reports for regulatory submission dossiers
• Create Risk Management Plans (RMP) and Risk Evaluation and Minimization Strategies (REMS)

Skills

• High ethical standards and a strong quality mindset
• Collaborative and proactive approach with effective communication skills
• Ability to build strong relationships with internal and external stakeholders

Education

• Master’s degree in a relevant field; PhD or additional qualifications in Drug Development or Pharmacovigilance preferred

Tools

• Experience with safety surveillance tools and regulatory submission processes