Head of PharmacovigilanceAbout Krystal Bio:
At Krystal Biotech, we bring together the brightest and most eager minds to relentlessly pursue the discovery, development, manufacturing, and commercialization of genetic medicines to treat diseases with high unmet medical needs.Founded in 2016, Krystal is distinguished in three powerful ways: science and technology using our patented gene therapy platform, innovative manufacturing supported by our commercial scale facilities, and a unique commercialization model that focuses on the patient’s end-to-end experience.Krystal received U.S.
FDA approval for the first and only redosable gene therapy treatment, VYJUVEK®, for the treatment of Dystrophic Epidermolysis Bullosa (DEB). Krystal continues to leverage our proprietary platform to rapidly advance a robust pipeline of investigational genetic medicines in respiratory, oncology, dermatology, and ophthalmology.Krystal is headquartered in Pittsburgh, PA, which is home to our two state-of-the-art CGMP manufacturing facilities with teams around the world and satellite offices in Switzerland, Germany, and Japan. We are a company built and run by people who care, are fearless in the face of a challenge, love the work they do, and practice the highest level of scientific integrity.
As we grow, we are seeking team members that embody these values.
Job Description Summary:
Krystal Biotech, Inc. is seeking a highly motivated Head of Pharmacovigilance to lead our pharmacovigilance efforts. The Head of Pharmacovigilance will be responsible for overseeing the safety of our clinical- and commercial-stage products throughout their lifecycle, ensuring compliance with global regulatory requirements, and risk management.
Primary Responsibilities:
- Develop and implement a comprehensive pharmacovigilance strategy to ensure the safety of Krystal’s products.
- Oversee the collection, analysis, and reporting of adverse event data in compliance with global regulatory requirements.
- Lead and manage the pharmacovigilance team, providing guidance, mentorship, and support.
- Collaborate with cross-functional teams to integrate safety data into the overall product development process.
- Ensure timely and accurate submission of safety reports to regulatory agencies.
- Develop and maintain standard operating procedures (SOPs) for pharmacovigilance activities.
- Conduct risk assessments and develop risk management plans for Krystal’s products.
- Serve as the primary point of contact for regulatory authorities on pharmacovigilance matters.
- Stay current with evolving regulatory requirements and industry best practices in pharmacovigilance.
- Provide safety expertise and support to clinical development programs, including protocol development and study design.
- Monitor and evaluate the safety profiles of Krystal’s products, identifying potential safety signals and implementing appropriate mitigation strategies.
- Prepare and present safety data to internal and external stakeholders, including regulatory agencies, investigators, and healthcare professionals.
Requirements and Desired Competencies:
- MD degree is required.
- 10+ years of experience in pharmacovigilance, with a proven track record of leadership in a pharmaceutical or biotechnology company.
- Recent oncology program experience, highly preferred.
- In-depth knowledge of global pharmacovigilance regulations and guidelines.
- Excellent organizational skills and attention to detail.
- Good presentation skills and excellent written and verbal communication skills.
- Interpersonal skills and ability to interact and work with staff at all levels.
- Ability to work independently and in a team environment.
- Ability to pay attention to details and be organized.
- Ability to project professionalism and handle multiple tasks in a fast-paced environment.
- Commitment to “internal client” and customer service principles.
- Proficiency in using pharmacovigilance databases and safety reporting systems.
- Ability to handle sensitive and confidential information with discretion.
- Ability to travel as required to support pharmacovigilance activities.
Krystal Biotech, Inc. is an Equal Employment Opportunity and Affirmative Action Employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender perception or identity, national origin, age, marital status, protected veteran status, or disability status. Headhunters and recruitment agencies may not submit resumes/CVs through this Web site or directly to managers. Krystal Biotech, Inc. does not accept unsolicited headhunter and agency resumes.
Krystal Biotech, Inc. will not pay fees to any third-party agency or company that does not have a signed agreement with Krystal Biotech, Inc.
