[Hiring] Director, Global Drug Safety & Pharmacovigilance Operations @Asahi Kasei

Role Description

This position of Director Global Drug Safety and Pharmacovigilance (GDSPV) contributes to the Company’s success in leading and providing direction for all product safety and pharmacovigilance activities in compliance with global pharmacovigilance and regulatory requirements. The incumbent serves as a safety liaison with the Company’s cross-functional teams and is responsible for oversight, strategic planning, and execution of pharmacovigilance, drug safety, case management and inspection readiness for investigational and marketed products, while striving for operational excellence and ensuring Company license partner and vendor contractual obligations are maintained.

Qualifications

• 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%

Requirements

• Contribute to the development of GDSPV Operation strategy, goals, and objectives and assist with the implementation and training to support department goals and initiatives.
• Manage all Company pre- and post-marketing safety surveillance activities for its products throughout the life cycle in compliance with International Council for Harmonization (ICH) guidelines, FDA/EMA applicable global health authority regulations related to Good Pharmacovigilance Practices (GVP), and Company procedures.
• Provide pharmacovigilance and drug safety leadership and input for the Company’s clinical development and postmarketing programs, including Clinical, Investigator Sponsored, Compassionate Use, Named Patient Use, and Disease Monitoring Programs.
• Contribute to the preparation and review of safety-related section(s) for clinical, regulatory, and scientific documents.
• Direct the creation and maintenance of the Company’s Core Safety Information (CCSI) and ensure implementation of CCSI in all Reference Safety Information (RSI).
• Oversee the preparation of pre- and post-marketing aggregate safety reports.
• Oversee risk-benefit evaluations and the preparation and review of Risk Management Plans (RMPs) for assigned products.
• Develop and manage pharmacovigilance activities and safety data exchange agreements with company’s license partners.
• Responsible for overall vendor performance and vendor service outputs.
• Develop and maintain pharmacovigilance quality system.
• Contribute to development and maintain the Pharmacovigilance System Master File (PSMF).
• Create and maintain standard operating procedures and working practices to ensure inspection readiness and compliance with regulations and guidelines.
• Serve as the company’s pharmacovigilance subject matter expert during audits and regulatory inspections.
• Manage pharmacovigilance budget and forecasting activities.
• Support signal detection activities to ensure signal identification, evaluation, and validation.
• Support preparation and participate in Safety Management Team (SMT), Benefit Risk Assessment Team (BRAT), and other forum meetings.
• Represent the company in product safety meetings with its license partners and CROs.
• Provide training to company personnel regarding pharmacovigilance requirements and compliance.
• Maintain current knowledge of global regulations and regulatory guidelines.
• May perform other drug safety and pharmacovigilance activities appropriate to experience and expertise.

Company Description