The Pharmacovigilance Manager role offers the opportunity to play a key part in ensuring patient safety and regulatory compliance within a global pharmaceutical environment. This position is ideal for professionals with strong pharmacovigilance expertise who are passionate about overseeing safety activities for both marketed and investigational products while collaborating with local and global stakeholders.
Responsibilities
Manage and promote overall Pharmacovigilance activities in Japan in accordance with GCP, GVP, GPSP and relevant regulatory requirements.
Implement appropriate Pharmacovigilance activities for Marketed Products and Investigational Products in compliance with regulatory requirements and SOPs.
Oversee the evaluation and reporting of domestic and foreign individual case reports for Marketed Products and Investigational Products.
Manage the evaluation and reporting of domestic and foreign research reports, including measures taken overseas.
Provide safety information to relevant internal and external stakeholders.
Implement and maintain Pharmacovigilance Agreements.
Maintain Pharmacovigilance awareness and training programmes.
Ensure readiness for Pharmacovigilance audits and inspections.
Plan, process and report aggregate safety reports to global teams and competent authorities.
Develop and maintain local Risk Management Plans.
Manage GPSP-related activities, including Specific Use-Result Surveys and Re-examination procedures.
Assist the Safety Contact Person (SCP) in fulfilling responsibilities and assume SCP duties during temporary absence.
Collaborate with regulatory authorities and cross-functional teams, including regulatory affairs, commercial and R&D functions.
Requirements
Bachelor's degree, Master's degree or higher in a scientific discipline such as pharmaceuticals, medicine or a related field preferred.
At least 3 years of experience in Pharmacovigilance-related activities.
Experience in Post-Marketing Surveillance activities is preferred.
Experience managing Pharmacovigilance operations, including responsibility for safety profiles of marketed and investigational products and supervision of relevant staff.
Strong understanding of Pharmacovigilance legislation and regulations under GVP, GCP and GPSP.
Excellent interpersonal, verbal and written communication skills.
Ability to research, compile and communicate safety information clearly and concisely to local and global stakeholders.
Coaching skills to support the development of team members.
Ability to manage subordinate operations, including progress management.
Experience supporting or participating in GCP, GVP and GPSP inspections conducted by competent authorities.
Benefits
Insurance and welfare coverage provided.
About the company
A company in the pharmaceutical industry, this global organisation develops, manufactures and markets medicines for dermatological and thrombotic conditions. Operating across more than 100 countries with a significant international presence, the organisation is committed to addressing unmet medical needs and improving patient outcomes worldwide.