[Japan] Pharmacoepidemiology Senior Lead (Global Risk Management)

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> This Pharmacoepidemiology Group is a cross-regional safety surveillance department. It plays a role in strategically monitoring the safety of Santen products and investigational products deployed worldwide.

<Position Role and PR to Candidates> Under a People centricity mindset, utilizing the abundant safety and efficacy data held by this department, you will lead proactive information dissemination to deliver peace of mind and trust to physicians and patients in medical settings, going beyond regulatory compliance.

Develop and support the company position for all safety topics of Santen products (Medicines and Medical devices) in all phases (post marketing and clinical development), including but not limited to ICSR case assessment, aggregate safety report (PSUR, DSUR, etc.), signal detection. Works collaboratively with Medical Evaluation, Safety Compliance, and Safety Operations to ensure an effective safety system Evaluates the benefit-risk balance of Santen products with Pharmaco-epidemiological approach which can analyze safety and the effects of medicines and medical devices on development and post-market by comparing and learning from other researches. Promotes the proper use of Santen products with medical and scientific background and competency. Provides safety strategy, identifies potential safety issues and recommends appropriate safety monitoring measures. Ensures the safety related global documents such as RMP, PSUR, Safety part of CCDS and DSUR are created and submitted to each competent authority with enough quality in a compliance. Initiates and contributes the scientific publication for scientific conferences and scientific journals Coordinates and facilitates GSVEM (Global Safety Vigilance Evaluation Meeting), ensuring that safety topics are brought up the GSVEM in timely fashion with high quality proposal. Supervise the PE team’s development, conduct, and completion of Post-Marketing Safety (PMS) studies. Develops, reviews and updates Standard Operating Procedures (SOPs) for the relevant safety vigilance activities for signal validation, exploration of external data sources (e.g., real world databases external to Santen) to comply with changes to standards, regulations and work practices Provides opinion to the overall processes, policies and procedures of safety vigilance Participates in internal/external audits for safety vigilance system as per scheduled and follows up on the post-audit processes to ensure closure of non-conformities and effective implementation of Corrective and Preventive Actions (CAPAs)

Establish the company position regarding safety matters of in-house products (medicines and medical devices) during both the development and post-marketing phases. Collaborate with Medical Evaluation, Compliance, and Operations functions to effectively implement safety surveillance activities. Evaluate the benefit-risk balance of in-house products during development and post-marketing through a pharmaco-epidemiological approach that analyzes the safety and efficacy of medicines and medical devices by utilizing various research data. Promote the proper use of in-house products by utilizing medical and scientific backgrounds and skills. Construct safety-related strategies, identify potential safety issues, and plan and execute appropriate safety monitoring activities. Supervise the creation and timely submission of safety-related global documents, such as RMP, PSUR, DSUR, and the safety part of CCDS, to each regulatory authority with sufficient quality. Lead publications such as conference presentations and papers. Preside over GSVEM (Global Safety Vigilance Evaluation Meeting) and support ensuring that high-quality and timely proposals regarding safety-related topics are made. Supervise the planning, execution, and completion of Post-Marketing Surveillance (PMS) studies managed by the Pharmacoepidemiology Group. Create, review, and update Standard Operating Procedures (SOPs) related to safety surveillance activities, such as safety signal validation and exploration of external data sources (e.g., real-world data outside the company), to respond to regulatory changes. Provide opinions toward the further improvement of overall safety surveillance processes, policies, and procedures. Participate in internal and external audits related to the safety surveillance system and post-audit responses, address non-conformities, and ensure the effective planning and execution of CAPAs.

・Bachelor’s Degree in a life science. Preferred: MD and Pharmacist

・Minimum of 10 years pharmaceutical industry, pharmaceutical industry safety surveillance, or applicable clinical/medical experience required.

・Ability to communicate with cross-functional and multi-region stakeholders globally.

・Excellent oral and written communication skills with excellent interpersonal skills and willingness to work in a team environment, cross functionally, and work with global groups.

・Highly organized and demonstrates understanding of workflow prioritization.

・Ability to multitask and triage as needed with the ability to work independently, under pressure, demonstrating initiative and flexibility.

・Excellent understanding of clinical trial methodology, GCP and medical terminology

・Attention to detail and quality focused with strong technical and problem-solving skills

・Excellent understanding of physiology, pharmacology, clinical study objectives, and the drug development process

・Strong computer skills including, but not limited to, creation of spreadsheets, templates, presentations and working with safety database applications.

・Bachelor's degree or higher in life sciences. MD or Pharmacist license preferred.

・10+ years of experience in the pharmaceutical industry (Safety, Clinical, or Medical Affairs departments).

・Ability to communicate globally with cross-functional and multi-region stakeholders.

・Excellent oral and written communication skills, excellent interpersonal skills, and a willingness to collaborate as a team within cross-functional global groups.

・Highly organized with the ability to prioritize various tasks.

・Ability to multitask and triage as needed, demonstrating initiative and flexibility to work independently even under pressure.

・Excellent understanding of clinical trials, GCP, and medical terminology.

・Attention to detail, quality-focused, with strong technical and problem-solving skills.

・Excellent understanding of physiology, pharmacology, clinical studies, and the drug development process.

・Strong computer skills, including creating Excel, Word, and presentations, and using safety databases.

(Scope of changes in job duties) All company business

(Scope of changes in work location) Headquarters and offices/branches nationwide

Career Building at Santen A career at Santen is an opportunity for you to make a difference. Through the long-term vision presented 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 diverse talents with team members around the world, providing flexible working styles and an inclusive work environment. As a result, we discover new solutions and drive 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 based on business needs, role requirements, and individual skill sets, without regard to race, color, creed, religion, sex, 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 accommodations during our recruitment process, please inform our recruitment team.