[Japan] ファーマコエピデミオロジーシニアリード (グローバルリスクマネジメントポジション)

• 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 teams 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)

• Safety issue
• RMPPSURDSURCCDS
• publication
• GSVEM (Global Safety Vigilance Evaluation Meeting)
• SOP
• CAPA

Qualifications :

Bachelors Degree in a life science. Preferred: MD and Pharmacist
Minimum of10 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.

10




GCP

:

Santen

SantenSantenSanten2030

SantenEqual Opportunity Employer //

Remote Work :

No

Employment Type :

Full-time