安全管理責任者
- Safety
Control
Manager/ GVP Controller
Who we are:
At Krystal Biotech, Inc., we bring together the brightest and most eager minds to relentlessly pursue the discovery, development and commercialization of gene delivery medicines for patients with serious and life-threatening genetic diseases. Founded in 2016, Krystal is a leader in gene therapy. Krystal received U.S. FDA approval for the first-ever redosable gene therapy treatment, VYJUVEK™, for the treatment of Dystrophic Epidermolysis Bullosa. Krystal continues to leverage our proprietary platform to develop new treatments across a robust clinical pipeline. Located near Krystal’s Pittsburgh, PA headquarters are two state-of-the-art GMP facilities.Join us on our journey to implement our mission to identify, develop and deliver genetic medicines to patents!
Job Description Summary:
The GVP Controller will be responsible for integrating Good Vigilance Practices (GVP) with Chemistry, Manufacturing, and Controls (CMC) to ensure the highest standards of product safety and regulatory compliance. This role requires a highly knowledgeable individual who can bridge the gap between pharmacovigilance and CMC, ensuring comprehensive oversight of product safety while overseeing the collection, assessment, and reporting of adverse events related to our pharmaceutical products. This role requires a detail-oriented individual with a strong understanding of pharmacovigilance regulations and practices.
Responsibilities will include, but are not limited to, the following:
- Ensure the maintenance and continuous enhancement of the pharmacovigilance (PV) system, fulfilling the duties of a Marketing Authorization Holder (MAH).
- Ensure compliance with local pharmacovigilance and safety regulations and standards, implementing necessary updates to company policies and procedures.
- Develop and maintain risk management plans that encompass both pharmacovigilance and CMC considerations.
- Conduct regular risk assessments to identify potential safety and quality issues, implementing risk minimization measures as necessary.
- Oversee the management and analysis of safety data and documentation, ensuring its accuracy, integrity, and completeness.
- Ensure that safety and quality considerations are integrated throughout the product lifecycle, from development to post-market.
- Prepare for and manage regulatory inspections and audits, addressing findings and implementing corrective actions.
- Collect, evaluate, and process adverse event reports from healthcare professionals, patients, and other sources.
- Supervise safety activities in local clinical studies and ensure compliance with post-marketing pharmacovigilance (PV) regulatory commitments.
- Work closely with clinical, regulatory, quality assurance, and medical affairs teams to ensure integrated safety management.
- Liaise with internal leadership and external partners including regulatory authorities ensuring that clear communication is provided.
- Collaborate with CMC teams to address any safety-related issues that arise during manufacturing and control processes.
Requirements and Preferred Qualifications:
- Bachelor’s degree in Pharmacy, Medicine, Life Sciences, or a related field. Advanced degree or certification in pharmacovigilance is preferred.
- Minimum of 5 years of experience in pharmacovigilance or drug safety within the pharmaceutical industry.
- Strong understanding of Japanese pharmacovigilance and safety regulations and guidelines, including those of the PMDA.
- Excellent analytical skills to assess and interpret safety data and identify potential safety issues.
- Strong written and verbal communication skills for effective safety communication and collaboration.
- High attention to detail to ensure accuracy in safety data management and reporting.
- Strong problem-solving abilities to address safety issues and implement effective risk management strategies.
- Strong organizational skills to manage multiple tasks and projects efficiently.
- Fluent in Japanese and English, both written and spoken.
