Job Description
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 When you join Sydnexis, you become part of a mission bigger than any one of us: to challenge outdated standards, disrupt the status quo, and deliver innovations that truly matter.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.
Job Tags
Full time, Local area,