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Date:  Jan 1, 2023
Location: 

Shanghai (CHN), CN

Job Type:  Long-term/regular

 Vigilance Manager M/F (26728)

 

At Guerbet, we build lasting relationships so that to enable people to live better. This is Our Purpose.

 

We are a global leader in medical imaging, offering an extensive portfolio of pharmaceuticals, medical devices, digital and AI solutions, for diagnostic and interventional imaging. As a pioneer in the field of contrast products since the last 95 years ,we continuously innovate. We dedicate 10% of our revenue to Research & Development such as to improve the diagnosis, prognosis and quality of life of patients.

 

Achieve, Cooperate, Care and Innovate are the values ​​that we share and practice on a daily basis.

 

Working at Guerbet is not only being part of a multicultural team of 2,600 people across more than 20 countries, but, it is above all about playing a unique role in the future of medical imaging.

 

For more information on Guerbet, go to www.guerbet.com and follow Guerbet on Linkedin, Twitter, Instagram and Youtube

 

I- Common missions for this position

   (geographical perimeter = China)

 

Pharmacovigilance (PV) / Medical Device Vigilance (MDV) case management

  • Collect local PV/MDV cases (reports of Adverse Drug Reactions (ADRs) / Adverse Events (AEs) / special situations / incidents) from healthcare professionals, patients, scientific and medical literature, competent authorities websites, medical information enquiries (MIEs), product quality complaints (PQCs), customer relationship management (CRM) tool, market research programs, and clinical studies. Also collect all relevant foreign PV/MDV cases from Global Vigilance department.
  • Report to Global Vigilance department the PV/MDV cases collected as well as requests for information from competent authorities.
  • Perform a local medical assessment of the PV/MDV cases, implement them in MAERS, report them to the competent authorities, and coordinate their monitoring with the National Centre for ADR Monitoring (NCADRM) as appropriate.
  • Record the PV/MDV cases in the Affiliate PV/Complaint case log.
  • Perform follow-up activities for local PV/MDV cases.
  • Perform local searches of PV/MDV cases in the published literature, including the collection of follow-up information from the authors.

 

Interactions with healthcare professionals and competent authorities

  • Submit periodic safety reports, response documents, and any information regarding changes in benefit/risk ratio of the products to the appropriate competent authorities.
  • Submit product risk management plans to competent authorities and manage risk minimization activities.
  • Answer to product-related safety questions from healthcare professionals with the support of the Global Medical Information department.
  • Report safety information to healthcare professionals via the PV/MDV Contact Persons of the distributors.

 

Other PV/MDV-related operations

  • Is responsible for the signature and implementation of a Safety Data 
  • Exchange Agreement (SDEA) / Medical Device Vigilance Agreement (MDVA) between the Affiliate and the Global Vigilance department.
  • Is responsible for the signature and implementation of Local SDEAs / Local MDVAs with all Affiliates’ partners in charge of product distribution and/or promotion.
  • Ensure PV audits are conducted at partners’ level.
  • Perform reconciliations with other data collection systems (MIE, PQC, CRM…).
  • Set-up a local system for the detection and management of safety signals, emerging safety issues, significant safety issues, public health threats.
  • Ensure local regulatory intelligence on PV/MDV matters.
  • Ensure business continuity in PV/MDV activities at Affiliate’s level.
  • Ensure global oversight on the local PV system through Safety Board meetings.
  • Ensure regular PV/MDV trainings of the Affiliate’s staff as well as PV Contact Persons of the partners.
  • Participate to PV/MDV audits by corporate departments and inspections by competent authorities.
  • Participate in the revision of the safety sections of the SmPC in collaboration with local Regulatory Affairs.
  • Participate in the creation/revision of local PV/MDV SOP.
  • Ensure the control of safety operations through self-inspections.
  • Record and store safety data and documents in secured formats and repositories.

 

II- Specific missions for this position

  • Acts as Local Responsible Person for Pharmacovigilance (LRPPV) and Local Responsible Person for Medical Device Vigilance (LRPMV) in China.
  • Is the Contact Person of the Chinese Health Authorities for any vigilance matter related to Guerbet products.

 

 

Educations & Experiences

  • 3-5 years’ work experience in PV for a pharmaceutical company (mandatory)
  • Experience in MDV

 

Skills & Qualifications

  • Good level in English.

 

Reason to join US

Much more than a Competitive salary,


We offer continued personal development. When you join Guerbet, you :

  • Are choosing a global leader with recognized expertise in diagnostic and interventional imaging, 
  • Are joining our 2820 collaborators who are committed every day to offering innovative solutions to improve quality of patient’s life all over the world,
  • Are joining a company where we value diversity of talents coming from various horizon.

 

We # Innovate # Cooperate # Care #Achieve at Guerbet. 

 

Guerbet is committed to a policy of Equal Employment Opportunity and will not discriminate against an applicant or employee based on race, color, religion, creed, national origin or ancestry, sex, sexual orientation, gender identity or expression, age, physical or mental disability, veteran or military status, genetic information, or any other legally recognized protected basis under federal, state, or local law. The information collected by this application is solely to determine suitability for employment, verify identify, and maintain employment statistics on applicants.

 

Applicants with disabilities may be entitled to reasonable accommodation under the Americans with Disabilities Act and certain state or local laws. A reasonable accommodation is a change in the way things are normally done which will ensure an equal employment opportunity without imposing undue hardship on Guerbet. Please inform the company’s personnel representative if you need assistance completing this application or to otherwise participate in the application process.

 

Guerbet provides accommodations to applicants and employees with disabilities. If you need an accommodation to apply for a position please send an email to careers@guerbet.com.