17920 Pharmacovigilance Senior Manager
・Authors and review applicable local and global SOPs that relate to J-GLPS activities, identifies and implements necessary changes in collaboration with GLPS S&C.
・Supports GVP Training Responsible person. Proposes and implements the annual training plan once approved by the Safety Manager.
・Supports GVP Self-Inspection Responsible person. Proposes and implements the annual self-inspection plan once approved by the Safety Manager.
・Communicates any areas of concern with respect to the training plan or self-inspection activities to the Safety Manager and oversees agreed corrective and preventive actions.
・Acts as a GVP archivist. Defines the filing and archiving process within J-GLPS, provides input to the GLPS Record Retention schedule and oversees the annual record review in J-GLPS.
・Conducts new starter AE training in Japanese to new staff where training in local language is required, using the GLPS core slides with supplementary local information where required.
・Supports Safety Manager by providing other GLPS related training to vendors and staff as required.
・Supports audit CAPA tracking for the team through to resolution and escalates continued non-conformance to the Safety Manager.
・Conducts self-inspection and reports the outcome to Safety Manager in writing.
・Lead the inspection readiness activities for Pharmaceutical License Renewal, new drug applications (NDAs) and reexamination of marketed products.
・Acts as a point of contact person with external license parties / distributors / service providers, and leads preparation / revision of PVA, MOU and/or safety contract agreement.
・Works in close collaboration with global GLPS in all Pharmacovigilance Matters but specifically for the above areas.
・Collaborate with Safety Manager, PMS Manager and General Marketing Compliance Officer (GMCO) as appropriate.
・7 yrs＋ Experiences in drug safety
・Registered Pharmacist (preferred)
・Bachelor, Master, or Doctor’s degree, or professional qualification in a life science field (e.g., nursing or pharmacy) or a relevant scientific/technical discipline with demonstrated experience with the responsibilities, deliverables, and skills required for this level.
・Strong familiarity with ICH/local guidelines and PMDA/MHLW notifications.
・Good skills of communication in Japanese and English (>730 TOEIC)
・Must have demonstrated organizational /project management skills to manage multiple/complex projects simultaneously.
・Proven good communication skills and evidence of able to work in cross functional teams.
・Hands-on involvement is a must (effective use of external resources).