[Japan] Risk Management Specialist, Japan Pharmacovigilance Team

Santen is a pharmaceutical company with a 130-year history specializing in ophthalmic healthcare. As a global company originating from Japan, we have bases in over 60 countries, providing various innovative treatments and digital solutions for eye health, and addressing social issues related to vision for people around the world. <Department or Team Introduction>

The role of the Japan Pharmacovigilance Team includes planning risk minimization measures through safety signal management analysis targeting global aggregate safety information, and promoting appropriate use through information dissemination via the analysis of large-scale clinical data generated from post-marketing surveillance (PMS, etc.). <Position Role and PR to Candidates> You will take on the role of "Product Safety Lead," leading the monitoring of the benefit-risk balance of assigned products (development products, marketed products). In addition to the abundant safety information collected daily from around the world, you will utilize efficacy and safety information from PMS—a characteristic of the GPSP regulatory department—to analyze data from various angles. Through collaboration with various stakeholders, you will disseminate messages to medical professionals and patients and provide solutions. Furthermore, you will perform aggregate reporting to regulatory authorities based on the obtained safety information. This is a position with great excitement and fulfillment, where you contribute to maximizing product value by gaining product safety and trust through proactive safety information dissemination that goes beyond mere safety reporting to regulatory authorities.

【Job Description】

You will be responsible for the entire process of collecting, analyzing, and disseminating safety information for pharmaceuticals and medical devices after marketing.

• Execution of signal management based on aggregate safety information and planning for the promotion of appropriate use, as well as planning and execution of risk management activities.

• Creation of implementation plans and analysis plans for post-marketing surveillance, execution of analysis, and preparation of summary reports.

• Preparation of RMP, periodic safety reports, re-examination application documents, ICH-PBRER, DSUR, and data preparation based on requests from local SV.

• Participation in the maintenance and updating of risk management systems in response to changes in the external/internal environment.

• Participation in the maintenance and updating of compliance systems due to changes in country-specific regulatory requirements.

【Required Qualifications】 3 or more years of professional experience in a safety department (pharmacovigilance), post-marketing surveillance department (PMS), or a department engaged in safety activities (specifically R&D, clinical development [excluding CRA], Medical Affairs, Medical Science Liaison, academic/non-clinical research, etc.) at an originator manufacturer of pharmaceuticals or medical devices. However, if holding a medical license, 3 or more years of experience in a safety department at a CRO, etc., is also acceptable. Individuals who possess both scientific analytical/planning skills combining knowledge of pharmacy and biochemistry, and communication skills with medical professionals. Hybrid work is possible (full remote is not possible). Must reside in the Kansai area and be able to commute to the Umeda Head Office when necessary (guideline: at least once every two weeks). English communication skills (capable of participating in web meetings and not hesitant about global communication). 【For those with safety department experience】 Those who are proficient in individual case evaluation, aggregate evaluation, benefit-risk analysis, or PMS data analysis, and have experience in information dissemination through communication with medical experts (KOLs) in addition to periodic reporting to authorities. Experience in presenting PMS results at academic conferences or writing papers is desirable. *Individuals whose experience is limited only to individual case evaluation are not eligible. 【Preferred Qualifications】 Individuals holding medical qualifications such as a physician (overseas licenses acceptable) or pharmacist. The country where the qualification was obtained does not matter. For those who obtained qualifications overseas, communication skills in both Japanese and English are mandatory.

Those with KOL management experience.

Knowledge in the ophthalmology field.

Experience in writing academic papers in medical fields.

Those with experience participating in development projects and proactively planning/organizing research or trials.

【Ideal Candidate Profile】 Individuals who can perform duties with a sense of mission under a People centricity mindset. Since this role involves frequent communication within the department and with related departments, individuals with a good sense of balance between cooperativeness and proactiveness, and high interpersonal skills. Individuals with a proactive attitude toward problem-solving. Individuals who do not shy away from steady, diligent effort. Individuals who can respond calmly even in emergencies. Individuals capable of logical and flexible thinking. Individuals with high communication and listening skills.

(Scope of changes in job description) All company business

(Scope of changes in work location) Head office and business sites/sales offices nationwide Career Building at Santen A career at Santen will be an opportunity for change for you. Through the long-term vision shown in "Santen 2030," Santen aims to be a social innovator that meets the social and economic needs of people with visual impairments. To achieve this, we leverage the diverse talents of our team members around the world and provide flexible working styles and an inclusive workplace environment. As a result, we discover new solutions and promote understanding of patients and innovation in treatment.

The Santen Group is an Equal Opportunity Employer. We are committed to building diverse teams and providing a safe and inclusive physical and virtual workplace for every team member. All employment is made on the basis of business needs, role requirements, and individual skill sets, without regard to race, color, ethnicity, origin/ancestry, religion, sexual orientation, gender, gender identity/expression, age, disability, medical condition, marital status, veteran status, or any other characteristic protected by law.

If you require any accommodation during our recruitment process, please inform our recruitment team.