Job Description

About This Role:

We are seeking a highly skilled and experienced Manager, Drug Safety to join our team in Tokyo, Japan. In this critical role, you will lead our drug safety and pharmacovigilance efforts, ensuring compliance with global regulations and maintaining the highest standards of patient safety.

Key Responsibilities:

• Serves as SME to oversee PV (Pharmacovigilance) activities, including  clinical trial activities, signal management, literature review, and ad hoc regulatory responses for assigned products, and monitors and manages resourcing for assigned products to ensure compliant, high-quality, timely deliverables.
• Ensure all of the PV acitivities to meet GVP (Good Vigilance Practicea) requirements and reports the results of execution to safety supervisor and pharmaceutical as needed
• Identifies process / procedural non-compliance, gaps or inefficiencies. Leads initiatives for process improvement; implements and maintains processes.  Manages staff and corrective actions when non-compliances are identified.  Serves as example for behaviors that lead to high quality outputs (i.e., quality checks, transparency, expert consultation, etc.)
• Management of contract with vendors, partners and others, management of PV training, Audit, SOPs creation and maintenance, documents archiving etc. 
• Outsourcing management: Manage and oversight vendors to fulfill compliance and quality required by Biogen 
• Take the responsibilities on re-examination and NDA, contribute to success in re-examination and NDA from safety perspective.
• May represent the role of Safety supervisor in case of Safety supervisor is absent, as needed.

Job Scopes:

• Support to senior associate level roles.
• Assigned for GVP responsible person.
• SME for all of PV activities both for assigned post-marketing products and investigational products.
• Vendor management
• Take roles in Re-examination
• Take roles in NDA processes.
• May assigned for deputy safety supervisor as needed.

Qualifications

Required Skills:

• Minimum 6 years experience in the pharmacovigilance with some experiences of GVP responsible person.
• Experiences with interacting with third parties (e.g., contract service providers) is preferred.
• Knowledges of ICH and Japanese regulatory requirements, especially in PV, and able to analyse the impact of regulatory intelligence.
• Experiences in GVP compliant quality systems is preferred.
• Experiences in creating package inserts, RMPs and RMP materials.                                             Experiences in pharmaceutical safety measures (revision of precautions for use, RMP creation and operation, etc.) and practical contribution experience.
• Experiences in new drug approval application work and contribution experience as the main person in charge.
• Experiences in dealing with Audi or inspections.

Preferred Skills

• Excellent communication skills including: technical writing skills, PC skills, and good questioning and analysis techniques desired.
• Must work effectively in a team environment and with individuals at all levels within an organization.
• Additional necessary characteristics include: being a self-starter, goal oriented, attention to detail, and ability to multi-task.
• Able to work independently with minimal guidance.
• Ensures appropriate resolution of any legal liability issues, and solves complex problems; decisions and problem solving are guided by policies, procedures and department plan complying with government regulations.

Education:

• B.S. degree required, science degree preferred

Additional Information

Why Biogen?

We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.

At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about our DE&I efforts.