Finland Senior Specialist Safety Vigilance Compliance Global
Finland Senior Specialist Safety Vigilance Compliance Global
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1 Vacancy
Job Description
Jobs 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 crossfunctional 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 :
- Bachelors 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 longterm 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.
Remote Work :
No
Employment Type :
Fulltime
Employment Type
Full-time
