Description

In this role, you will lead and contribute to patient safety and pharmacovigilance activities, ensuring the safety and efficacy of drugs in development and on the market. Your work will involve designing safety strategies, collaborating across departments, and interpreting clinical data to enhance patient health outcomes.

Requirements

• •Medical Doctor with clinical or clinical research experience
• •PV experience and good understanding of PV regulations in major markets
• •Experience in clinical development and submissions for marketing authorization
• •Clinical or research experience in cardio-renal-metabolism areas
• •Strong interpersonal and communication skills
• •Strong ethical sense and quality and patient safety mindset
• •Excellent English skills, both written and spoken
• •Extensive experience in PSPV and Risk Management in a pharmaceutical company
• •Very good understanding of the pharmaceutical industry and future trends in pharmacovigilance
• •Thorough understanding of PV regulations in major markets and compliance needs
• •Project management and leadership competencies

Tasks

• •Design and implement safety evidence strategies
• •Develop patient-centric risk minimization strategies
• •Plan and manage pharmacovigilance activities for assigned drugs
• •Set up safety analyses in clinical trial databases
• •Continuously monitor and develop product safety profiles
• •Manage safety signals effectively
• •Collaborate with Clinical Development and Global Patient Engagement
• •Work with Global Epidemiology and Medical Affairs on post-authorization studies
• •Interpret clinical trial safety data for reports and submissions
• •Review and provide input on regulatory documents
• •Update senior management on drug safety profiles
• •Recommend pharmacovigilance activities to decision-making committees
• •Chair internal multidisciplinary Asset Benefit Risk Teams (Senior position)
• •Represent Patient Safety and Pharmacovigilance in committees (Senior position)
• •Contribute to the development of Patient Safety and Pharmacovigilance methodologies (Senior position)