[Finland] Senior Specialist, Safety Vigilance Compliance (Global)

Company Description

As a specialized company dedicated to eye health, Santen aspires to contribute to the realization of “Happiness with Vision” by providing valuable products and services to patients, consumers, and medical professionals around the organization. Since its establishment in Japan in 1890, and guided by its CORE PRINCIPLE, “Tenki ni sanyo suru,” Santen has been committed to helping people maintain and improve their eye health, and is engaged in the global research and development, manufacturing, and sales and marketing of pharmaceutical products in the field of eye care, supporting the eye health of approximately 50 million people worldwide. Our duty is to create a future in which as many patients and consumers as possible can lead happy and fulfilling lives, we will continue to contribute to the realization of better eye care by providing solutions that eliminate bottlenecks in the diagnosis and treatment of eye diseases, thereby revolutionizing the treatment flow.
Each of us is deeply committed to challenging ourselves, building an organization that brings together diverse internal talents and external expertise, and to doing our utmost to realize a society in which people everywhere can feel happy through vision-related experiences. Isn't it exactly the kind of environment you want to belong in?

Job Description

Job’s mission

• A Senior specialist shall work closely with the Head, Senior Managers, Supervisors/Managers, Specialists in the group to help ensure that Santen Safety Vigilance (SV) complies with global standards, policies and procedures related to Safety vigilance.
• Ensure the safety of patients treated with Santen products.
• Contribute to the global safety vigilance compliance of the company with keeping a 100% compliance.

As Senior specialist, working within the Global SV compliance has the following primary responsibilities:

• Provides training to concerned persons based on the training plan and managing training documentation; archive documents according to prevailing standards.
• Supports in the procedures of global pharmacovigilance operations such as Standard Operation Procedures (SOPs), internal business practices or working instructions.
• Supports cross-functional continual improvements projects that enable a compliant quality systems in the SV system.
• Facilitates operational meetings.
• Participation in the processes of involving the collection, processing, review and distribution of adverse event information regarding development and marketed Santen products.
• Performs local literature searches within designated area.
• Performs regulatory intelligence within designated area.
• Performs Vendor Management including PV agreement maintenance.
• Supports audits, inspections and CAPAs management.
• Support activities related to Santen Pharmacovigilance System Master File (PSMF).
• Maintains tools for generating KPIs.
• Supports project leadership in any ad hoc / peak demand areas.

Qualifications

• Bachelor's Degree in a Life Sciences discipline is required.
• Minimum of 3 years of direct experience in a safety vigilance /pharmacovigilance environment within pharmaceutical industry is required.
• Experience and preference for working in multicultural environment.
• Safety Database systems and knowledge of medical terminology is required.
• Good understanding of Post marketing safety requirements.
• Proven ability to work with a high level of integrity, accuracy, and attention to detail.
• Fluent English language skills.

Additional Information

A career at Santen is an opportunity to make a difference. Through our long-term vision outlined in Santen 2030, we are committed to be a Social Innovator - addressing the social and economic needs of people with visual impairments. We have team members around the world using their diverse talents to unlock new modalities and drive innovations for patient outcomes, education and treatment. At Santen, we believe in empowering all our team members with flexible ways of working and a highly inclusive work environment.

The Santen Group is an Equal Opportunity Employer. We are committed to building diverse teams and ensuring a safe and inclusive physical and virtual workplace for every one of our team members. All employment decisions are based on business needs, role requirements and individual qualifications regardless of race, color, ethnicity, national origin/ancestry, religion, gender, gender identity/ expression, age, disability, medical condition, marital status, veteran status, or any other characteristic protected by law.