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Head of Pharmacovigilance

Head of Pharmacovigilance

Sydnexis IncUS
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About Sydnexis :

  • Sydnexis Inc. is a clinical-stage biopharmaceutical company united by a single purpose : helping children see clearly.
  • We are developing a proprietary, stable, topical eye drop designed to slow the progression of myopia, a disease that affects more children today than ever before.
  • Our team has filed a New Drug Application (NDA) with the FDA for our patented formulation, marking an important milestone in redefining the standard of care in pediatric eye health.
  • At our core, we believe every child deserves the chance to see their world, and their future, with clarity.
  • This belief drives us every day.

When you join Sydnexis, you become part of a mission bigger than any one of us :

  • to challenge outdated standards, disrupt the status quo, and deliver innovations that truly matter.
  • Here, you’ll find a tight-knit, purpose-driven team building something extraordinary together, and the opportunity to make a lasting impact on children’s lives.
  • Position :

  • The Head of Pharmacovigilance (PV) will lead, develop, and manage PV operational activities, ensuring compliance with global regulatory requirements and internal standards.
  • This role offers an exciting opportunity to create a dynamic PV operation that contributes to the safety and efficacy of products in clinical development, potentially leading to an upcoming launch.
  • Role and Responsibilities :

  • Ensure compliance with relevant regulatory requirements and guidelines for pharmacovigilance activities.
  • Manage the processing of adverse event cases (Individual Case Safety Reports) and aggregate reporting (Development Safety Update Reports,) to guarantee the timely submission of high-quality safety reports to regulatory agencies and external stakeholders.
  • Collaborate with clinical Medical Monitors to conduct medical reviews and assessments of individual adverse drug reaction reports.
  • Serve as the primary liaison between internal departments and external partners on operational issues related to pharmacovigilance.
  • Develop and update drug safety forms and templates, ensuring they are harmonized with clinical operation forms during study initiation and throughout the study maintenance phase as necessary.
  • Manage relationships with pharmacovigilance vendors, overseeing the execution of responsibilities and ensuring compliance with safety data processing and submission activities.
  • Lead the preparation and review of safety-related sections in clinical and regulatory documents.
  • Develop and implement process improvements, tools, systems, and procedures for pharmacovigilance.
  • Provide input for responses to regulatory inquiries and safety-related issues.
  • Contribute to the development and updating of safety documents, including core data sheets, investigator's brochures, product labels, and Risk Management Plans (RMPs) as required.
  • Participate in regulatory inspections and internal audits, and draft responses to findings when necessary.
  • Qualifications :

  • A bachelor's degree in health sciences, life sciences, or biotechnology is required.
  • A background as a healthcare professional (e.g., MD, RN, BSN, PharmD, or Physician Assistant) is preferred.
  • A minimum of 10 years of pharmacovigilance (PV) experience is required, with at least 5 years in a successful management role.
  • Demonstrated strong knowledge of global PV regulations, including EU and US regulations, ICH guidelines, and Good Clinical Practice (GCP).
  • Extensive experience in drug safety and PV within a biopharma environment or a clinical research organization, along with successful management experience.
  • Proficiency in safety databases (e.g., Argus), regulatory regulations, and MedDRA coding is essential.
  • Excellent interpersonal, organizational, and communication skills are required.
  • Strong project management and problem-solving abilities are necessary.
  • A solid understanding of Good Pharmacovigilance Practices, international PV regulations and guidance, clinical trial methodology, GCP, and medical terminology is essential.
  • This position is remote and requires occasional travel for business purposes.
  • Sydnexis Inc. is an Equal Opportunity Employer.
  • We are committed to providing a work environment free of discrimination and harassment.
  • We do not discriminate based on race, color, religion, sex, national origin, age, disability, genetic information, or any other characteristic protected by federal, state, or local law.
  • We are also committed to making our hiring process accessible to individuals with disabilities and will provide reasonable accommodations upon request.   Powered by JazzHR
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