Global Compliance Specialist (temporary)

Posted 14 Days Ago
Be an Early Applicant
Tampere, FIN
Hybrid
37K-52K Annually
Junior
Healthtech • Pharmaceutical
The Role
Provide pharmacovigilance compliance support during a maternity cover: deliver training and documentation management, support global PV SOPs and regulatory intelligence, label safety variations, back up adverse event collection/review, assist PSUR preparation and QCs, support audits/inspections and CAPA in QMS, maintain PSMF activities, and oversee LPPV network documentation.
Summary Generated by Built In
Company Description

Santen is a specialized company with a proud 130-year heritage focused exclusively on eye health. As a Japan-originated, global company with our footprint in over 60 countries and regions, our mission is to provide essential and significant value to patients and society through our products and services created from our expertise in ophthalmology and from the patient’s perspective.

Job Description

This is a maternity cover position, running from July 2026 to July 2027.

We welcome applications from professionals at both Specialist and Senior Specialist level. The role will be tailored accordingly depending on the candidate’s experience and seniority.

A Senior Specialist, SV Compliance will collaborate closely with the Head of SV, Senior Managers, Supervisors/Managers, and Specialists across global functions as well as the EMEA region to ensure that Santen Safety Vigilance (SV) consistently meets global standards, policies, and procedures related to safety vigilance.

What you will do

  • Provides training to concerned persons based on the training plan and managing training, documentation and 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
  • Performs regulatory intelligence within designated area
  • Performs safety variation for labeling changes
  • Supports as a backup for participation in processes involving the collection, processing, review, and distribution of adverse event information related to the development and marketed Santen products  
  • Supports PSUR preparation and QCs  
  • Supports audits and inspections. Performs CAPA management in Santen's Quality Management System (QMS)
  • Supports activities related to Santen Pharmacovigilance System Master File (PSMF)
  • Supports oversight of the network for Local Persons Responsible for Pharmacovigilance (LPPVs) including documentation and achieving documents

Qualifications

What you will bring to the role

  • Bachelor’s Degree in a Life Sciences discipline 
  • With first experience within the pharmaceutical industry
  • English: Fluent, Finnish: Native

Nice to have:

  • Direct experience in a safety vigilance/pharmacovigilance environment within the pharmaceutical industry 
  • Good understanding of EU GVP
  • Good understanding of PV operations, including case management processes
  • Good understanding of post-marketing safety requirements

What we offer:

  • Competitive Salary: A market‑aligned base salary starting from €37 491,00 - €51 550,00 depending on experience and location.

Ready to make a difference?  

Apply today and help us shape the future of eye health. 

Additional Information

Grow your career at Santen
A career at Santen is an opportunity to make a difference. We aspire to contribute to the realization of “Happiness with Vision” by providing eye health products and services to patients, consumers, and medical professionals around the world. Guided by our CORE PRINCIPLE, “Tenki ni sanyo suru”, Santen is engaged in the global research & development, manufacturing, and sales and marketing of pharmaceutical products in ophthalmology. 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, 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 kind of accommodation during our recruitment process, please let the recruiter from our team know.

Skills Required

  • Bachelor's degree in a Life Sciences discipline
  • First experience within the pharmaceutical industry
  • Fluent English
  • Native Finnish
  • Direct experience in safety vigilance/pharmacovigilance (nice to have)
  • Good understanding of EU GVP (nice to have)
  • Good understanding of PV operations, including case management processes (nice to have)
  • Good understanding of post-marketing safety requirements (nice to have)
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The Company
HQ: Ōsaka
1,218 Employees

What We Do

As a specialized company dedicated to ophthalmology, Santen carries out research, development, marketing, and sales of pharmaceuticals, over-the-counter products, and medical devices. Santen is the market leader for prescription ophthalmic pharmaceuticals in Japan and its products now reach patients in over 60 countries. With scientific knowledge and organizational capabilities nurtured over a 130-year history, Santen provides products and services to contribute to the well-being of patients, their loved ones and consequently to society. Santen Pharmaceutical Official Social Media Global Terms of Use​ https://www.santen.com/en/legal

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