The Company

iNova is a different kind of health company. We are leading the way to better health by delivering innovative, patient-centric products that improve the lives of people around the world. Our diverse portfolio of iconic, market-leading consumer health brands and prescription medicines are backed by science and distributed in over 75 markets across Asia, Australia, New Zealand, Middle East & Africa and Europe. Experience the iNova difference today.

The Opportunity

We currently have an opportunity for a Patient Safety & Medical Manager to join our Medical and Regulatory Affairs team on a full-time basis.

Reporting to the Japan Country Lead, this role primarily serves as the designated Anseki for iNova Japan, with responsibilities in Patient Safety & Pharmacovigilance Control Management and Medical Affairs. The primary purpose of this position is to ensure safety compliance of iNova Japan's pharmaceutical products post-marketing while also supporting the strategic delivery of iNova's commercial objectives through medical governance and scientific engagement.

This role is pivotal in maintaining regulatory excellence, ensuring patient safety and enabling business growth through credible medical support and promotional compliance.

Key Accountabilities & Performance Indicators

Patient Safety & Pharmacovigilance (Anseki)

• Establishment and maintenance of a GVP post-marketing safety management system in compliance with the MAH requirements and regulations in Japan.
• Supervision of local safety surveillance activities and monitoring systems in Japan as the GVP Controller ("Anseki").
• Responsible for the overall collection, review and evaluation of domestic and international safety information and timely reporting to regulatory authorities.
• Ensure all safety-related activities comply with PMDA regulations and internal company procedures.
• Preparation and revision of SOPs for GVP.
• Accountable for overall management and performance of all local safety management programs and operations, including self-inspections and implementation of education and training programs for all internal iNova Japan staff and any external business partners (where relevant).
• Responsible for developing local post-marketing surveillance safety documents (e.g. J-RMP) in cross-functional team in compliance with GVP and relevant company SOPs.
• Oversee the revision of Package Inserts based on the guidelines and negotiation with PMDA and relevant internal departments.
• Communication of information (e.g. instructions to pharmaceutical information officers) in connection with any revision of the "Precautions for Use".
• Identify and manage safety risks associated with iNova's pharmaceutical products in the Japanese market.
• Maintaining inspection readiness for PV audits and inspections.
• Authoring and oversight of response to regulatory queries for post-marketing safety matters in collaboration with relevant functions including Global Patient Safety and Risk Management team.
• Participate in other assigned global Patient Safety/Pharmacovigilance activities as feasible.

Medical Affairs

• Provide high-quality medical information for existing brands/products to internal and external customers.
• Work collaboratively and cross-functionally to support business goals, providing medical input as needed.
• Ensure all product complaints and adverse event reports are appropriately received/identified.
• Review promotional material for compliance with relevant regulations and Codes.
• Identify and disseminate new and/or relevant medical literature relevant to iNova brands.
• Support the Commercial team as needed on new product development and claims substantiation.
• Work collaboratively with the Regional and Global team on new product development and innovation pipelines.
• Identify and advise on competitor challenges, claims reviews and medical compliance with educational events and symposiums.

Other projects

Other global, local and ad-hoc projects related to Regulatory Affairs and Medical Affairs tasks may be assigned based on the skill and experience.

The successful applicant should possess the following qualifications and skills:

• Bachelor's Degree required
• Pharmacist License required
• 10-15 years solid Pharmacovigilance and/or Medical Affairs background in the pharmaceutical industry
• Good Pharmacological / Pharmaceutical / Clinical knowledge
• Deep understanding of Japanese GVP and international safety standards.
• Deep understanding of biology, pharmacology and therapeutic areas.
• Ability to interpret clinical data and stay updated on medical literature and guidelines.
• Capacity to manage multiple projects and deadlines in a fast-paced environment.
• Strong organizational skills and prioritization.
• Ability to work cross-functionally with multiple stakeholders – global and regional teams.
• Competence in reviewing and approving promotional materials, training content and scientific publications.
• Ability to write clear, accurate and compliant medical content.
• Experience engaging and communicating with Key Opinion Leaders (KOLs), healthcare professionals, and cross-functional teams.
• Demonstrated strong interpersonal, communication and influencing skills.
• Demonstrated leadership skills; proven decision-maker, hands-on and action-oriented style.

Personal attributes

• Ability to work effectively within a team in a fast-paced environment.
• Strong organizational, planning and follow-up skills.
• Proficient in Microsoft Office.
• High level of attention to detail and accuracy.
• Self-motivated, able to prioritize, multi-task and meets deadline in a timely manner.
• Positive, proactive attitude and a keen learner.
• Decisive, self-motivated.

Additional Requirements / Working Conditions

• Adhere to company values at all times

If you wish to be part of an energetic team within a thriving organisation, focused on bringing innovative products to market, please APPLY TODAY We want you to join us in our pursuit of healthy living