Director, Global Drug Safety – Pharmacovigilance Operations
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Job Description
Director leading global drug safety and pharmacovigilance operations for Asahi Kasei Therapeutics’ specialty pharmaceuticals. Overseeing surveillance, regulatory compliance, vendors, safety systems, and risk management.
Responsibilities:
- Lead and provide direction for all product safety and pharmacovigilance activities in compliance with global requirements
- Develop GDSPV operations strategy, goals, objectives, implementation, and training
- Manage pre- and post-marketing safety surveillance activities throughout product lifecycles
- Provide pharmacovigilance leadership for clinical development and postmarketing programs while collaborating with internal and external stakeholders
- Prepare and review safety sections of clinical, regulatory, and scientific documents and submissions
- Direct creation and maintenance of Core Safety Information and Reference Safety Information
- Oversee aggregate safety reports, including PSURs/PBRERs, PADERs, DSURs, IND Annual Reports, and SUSAR line listings
- Oversee risk-benefit evaluations and Risk Management Plans
- Develop and manage pharmacovigilance activities and safety data exchange agreements with license partners
- Govern vendors, including adverse event/product complaint call centers, outsourced ICSR processing, monitoring reports, and safety database operations
- Develop and maintain the pharmacovigilance quality system and Pharmacovigilance System Master File
- Create and maintain SOPs and working practices for inspection readiness and regulatory compliance
- Serve as pharmacovigilance subject matter expert during audits and regulatory inspections
- Manage pharmacovigilance budget and forecasting
- Support signal detection, safety assessments, and Safety Management Team and Benefit Risk Assessment Team meetings
- Represent the company in product safety meetings with license partners and CROs
- Provide pharmacovigilance training and manage training compliance
- Maintain current knowledge of global regulations and guidelines
Requirements:
- Bachelor’s degree in scientific / technical discipline, RN, or equivalent healthcare experience
- At least 7 years’ drug safety experience in the pharmaceutical industry
- Strong knowledge of US and EU pharmacovigilance regulatory requirements and current pharmacovigilance practices
- Solid experience with drug safety databases, especially with Argus
- Solid vendor management/governance experience
- Self-motivated, detail-oriented, with the ability to prioritize and plan effectively
- Excellent leadership qualities and written and verbal communication skills
- Ability to work in a dynamic, fast-paced environment with shifting priorities
- Experience with internal audits and global regulatory inspections
- Strong organizational and project management skills
- Proficiency in MS Office (Word, Excel, PowerPoint, Outlook) and Adobe Pro
- Travel Requirements: <10%
Benefits:
- Equal opportunity employer committed to a diverse workforce
- Remote work arrangement
- Travel requirements: <10%
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