Quality

PV Specialist

Address: 14F, FKI Tower, 24, Yeoui-daero, Yeongdeungpo-gu, Seoul, Seoul 07320, Korea, Republic of

Job ID: R0185182

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As a Clinic Manager at Fresenius Medical Care, you’ll manage the daily operations of our outpatient centers. More importantly, you’ll be the key driver in carrying out our mission: To deliver superior care that improves the quality of life of every patient, every day, setting the standard by which others in the health care industry are judged. This is accomplished by hiring, developing and inspiring a multi-disciplinary team, collaborating with physicians, tracking and delivering superior patient outcomes and monitoring regulatory and safety requirements. Strong management skills are required and prior direct patient care experience is needed for occasions when the team needs a helping hand.

A female nurse examining her patient

Patient Care Technicians (PCTs) at Fresenius Medical Care support and collaborate with RNs to provide dialysis treatment to several patients at a time while maintaining the functionality of the clinic. This involves prepping and testing equipment, reviewing treatment sheets, and opening the clinic at 4am for first shift. PCTs have a combination of technical skills and genuine passion needed to develop deep relationships with patients and improve their quality of life. Qualified candidates have prior customer service, healthcare and direct patient care experience, and will have the opportunity to learn the discipline of dialysis.

A female nurse examining her patient

Fresenius Medical Care nurses are on the front line of patient care, improving the quality of life of every patient, every day. That means providing dialysis care to 10-12 patients at any given time, and collaborating with our multi-disciplinary team to deliver a unique care plan to each one of them. This role is all about relationships and the bond you’ll create with patients and their families. Prior dialysis nursing experience is helpful, but many successful candidates come from a background in ICU, PCU and/or surgery.

A female nurse examining her patient

Job Description

KEY RESPOSIBILITIES

1. Adverse Event (AE) and Safety Data Management

  • Collect, process, translate, and submit AEs from all sources (PMS, QA, and Medical Information) to CDS in compliance with local regulations.
  • Manage the safety database, including data entry, consistency review, follow-up reporting, and document archiving.
  • Perform local literature screening for safety-related content.

2. Compliance and Reporting

  • Monitor the timeliness of expedited reporting, PSUR submissions, and PV training completion.
  • Conduct case reconciliation with relevant departments and business partners to ensure compliance.
  • Maintain local regulatory intelligence, assess its impact on processes, and communicate changes to CDS.
  • Perform local or global PV audit.

3. Risk Management and SOP Implementation

  • Establish and implement the Risk Management Plan (RMP).
  • Generate and maintain SOPs to ensure adherence to local regulatory requirements.

4. Training and Communication

  • Provide PV training to internal staff, new hires, and external partners (including agencies and CROs).
  • Receive and forward health authority communications to CDS.

JOB QUALIFICATION

  • Bachelor’s degree in pharmacy or a related field.
  • Licensed Pharmacist (Mandatory).
  • Minimum 2 years of experience in Pharmacovigilance (PV) in the pharmaceutical or medical device industry.
  • Strong knowledge of local regulatory requirements and global PV guidelines (e.g., ICH, GVP, and local health authority regulations).
  • Proficiency in safety data management systems and reporting tools.
  • Excellent communication and collaboration skills with internal teams, health authorities, and external partners.
  • Ability to conduct literature reviews and manage safety-related processes effectively.
  • Detail-oriented with strong analytical and problem-solving skills.
  • Proficiency in both English and Korean (written and spoken) for regulatory reporting and communication.

Success Profile

What makes a successful member of our team? Check out the top traits we are looking for and see if you have the right mix.

Success profile proportion

Success Profile

What makes a successful member of our team? Check out the top traits we are looking for and see if you have the right mix.

Success profile proportion

Success Profile

What makes a successful member of our team? Check out the top traits we are looking for and see if you have the right mix.

Success profile proportion
“You have a lot of independence...so the doctors trust you. You have to be able to make decisions on your own.”
Lesly,
Inpatient Services RN

We've got your back.

We fully believe that dedication and passion should be recognized and rewarded. That’s why we offer a competitive compensation and benefits package to all of our employees. Our benefits provide the flexibility, choice and support you need to be at your best as you play a vital part in helping patients live longer, better and healthier lives.

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