Pharmacovigilance Manager

About This Role

The PV Manager for China is a key team member of the local pharmacovigilance (PV) team providing PV support to the Head of Drug Safety, China and the rest of the local PV and R&D team. The role is accountable for performing, supporting and managing end-to-end PV activities (pre-authorization and post-marketing) in compliance with all applicable local regulations, guidelines, and global business requirements. The PV Manager also needs to liaise with local PV vendors, internal stakeholders, and relevant associations (such as RDPAC) to ensure quality and compliance of assigned PV tasks.

What You'll Do

• Support and contribute to establishing and maintaining a local PV structure and related practices in compliance with local Regulation and in synergy with Biogen's Global PV system.
• Lead and prepare relevant HA required PV documents including but not limited to PV Annual Report, Drug Annual Report etc. Ensure and oversee all the HA submissions (ICSRs, PSURs, DSURs) are compliant with local regulation required timeline and with high qualities.
• Act as the local expert in PV matters within the post-marketing space and the aligned territory and provide strategic and operational consultation to the local business. Contribute to PV matters in the pre-authorization space as required in collaboration with Global PV and other China R&D functions.
• Author local documents, such as job Aids (JAs), Standard Operating Procedures (SOPs), Vendor Service Agreements, and ensure content alignment with Global procedures and local regulatory requirements; ensure regular updates of these documents as per the established review cycles and as required according to enhancement needs.
• Work with China R&D, Medical Affairs, Marketing & Sales team on Clinical trial, Post-marketing studies, Organized Data Collection Programs such as Market Research, Patient Support Programs (PSPs), Social Media Programs which are relevant to local territory, ensure the appropriate PV processes are built, ensure adherence with global PV governance structure and procedures.
• Act as the back-up contact person for local audits and as required for local HA Inspections (including the interviewee role and collating responses to document requests); play a lead role in the facilitation and coordination of local audits and inspections in collaboration with the applicable Quality team and line manager. Prepare and execute CAPA related to PV audits and inspections.
• Contribute and participate in pre-marketing relevant PV activities (such as drafts the Safety Management, Clinical Risk Management Plan, etc.) and actively involves in study documents review if needed.
• As the backup person of LPPV when necessary.

• Minimum of bachelor's level degree in medicine, pharmacy, or other health care related profession or life sciences required, the master's degree is preferred.
• At minimum 5 years working experience in pharmaceutical industry setting, at least 3 years' experience in Drug safety area. Experience of interacting with third parties (e.g. PV operations vendors) is preferred.
• In-depth knowledge of Global, Regional, and local PV regulations and requirements.
• Well-developed technical writing skills with the ability to produce clear, concise documentation and communications. Good presentation and analytical skills.
• Having effective managerial skills (as applicable to job role and scope), is a self-starter, ability to adapt - to work independently or as part of a team, goal oriented, attention to details and accuracy, and ability to multi-task and prioritize.
• Excellent written and verbal communication skills.
• Excellent project management skills.
• Good proficiency with common software such as Microsoft Word, Excel, PowerPoint, Outlook.

• Experience in multi GxP domains and relevant quality systems.
• Experience with global PV databases (such as Argus, ArisG, VEEVA).