• Job Description

  Req#: 29971

  Pharmacovigilance Supervisor M/F (29971 )

  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 related to the function:

  1. Participate to the scientific and international regulatory intelligence. Provide expertise and support to analyze the impact of new scientific or regulatory information.
  2. Maintain and update the quality documentation on his/her perimeter.
  3. Check the compliance to quality referential on his/her perimeter.
  4. Participate to the preparation and conduct of vigilance audits and inspections. Participate to the implementation and follow-up of corrective and preventive actions.
  5. Elaborate or contribute to the elaboration of training materials related to his/her field of activity.
  6. Inform the Head of Global Vigilance and Medical Information (GVMI) department of the Group and/or the Head of Regional Vigilance and/or the APAC Vigilance Manager of any emerging issue, any incident or any information which may influence the security of the medicinal products or the medical devices, or may need to be reported to health authorities.

  II- As Guerbet India Affiliate’s LRPPV (Local Responsible Person for Pharmacovigilance ( PV)) and LRMPV (Local Responsible Person for Medical Device Vigilance ( MDV))

  (geographical perimeter = India)

  1. Be responsible for ensuring that the affiliate and the local distributors (partners) comply with PV/MDV obligations, by implementing the vigilance agreements (SDEA and MDVA) and their subsequent amendments (customization of the template according to local regulations) and ensuring their compliance with the quality documents and the local regulations.

  1. Ensure the compliance of the below Vigilance operations.

  • PV/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.
  • Report the PV/MDV cases to the Global Vigilance department.
  • Perform a local medical assessment of the PV/MDV cases and submit them to the Competent Authorities after they were processed by the GVMI team.
  • 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 domestic 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 GVMI department.
  • Report safety information to healthcare professionals via the PV/MDV Contact Persons of the distributors.

  • Other PV/MDV-related operations and Quality Assurance in PV

  • Be responsible for the signature and implementation of a Safety Data Exchange Agreement (SDEA) / Medical Device Vigilance Agreement (MDVA) between the affiliate and the GVMI department.
  • Be responsible for the signature and implementation of Local SDEAs / Local MDVAs with all affiliates’ partners in charge of product distribution and/or promotion.
  • 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 or 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 in the revision of the safety sections of the SmPC in collaboration with local Regulatory Affairs.
  • Ensure the control of safety operations through self-inspections.
  • Record and store safety data and documents in secured formats and repositories.
  • Create and update the local Pharmacovigilance System Master File in compliance with local requirements.
  • Ensure PV audits are conducted at affiliate and partners’ level, and work for CAPA development and implementation.
  • Establish and maintain a local QMS system for PV/MDV by creating and revising the local standard quality documents in compliance with Guerbet HQ standards as well as local regulations.
  • Ensure the compliance of PV/MDV operations at affiliate’s and handle the deviations on nonconformities.
  • Support the clinical team on local implementation of post-market requirement on phase IV and PMS studies, and their safety reporting.
  • Manage the submission of all regulatory documents to CDSCO as imposed as post-market requirements.
  • Ensure the tracking and compilation of the implementation records on post-market commitment.

  III- Specific missions for this position

  • Act as Pharmacovigilance Officer In-charge (PvOI) with responsibilities for dealing PV activities as authorized person by the company management, and required in Indian regulations. As a consequence:

  • The PvOI must reside in India.
  • The PvOI must have sufficient authority over the PV system in order to promote, maintain and improve its compliance.

  • Be the Contact Person of the Indian Competent Authorities for any vigilance matter related to Guerbet products and respond to queries of such authorities.

  Educations & Experiences

  • More than 5 years’ work experience in PV for a pharmaceutical company (mandatory).
  • Experience in MDV (preferred).

  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 an Equal Opportunity Employer. As an organization, we believe that no individual should be discriminated against because of their differences, which includes the following: age, disability, ethnicity, gender, gender identity and expression, religion, or sexual orientation. All employment decisions shall be made without regard to age, race, creed, color, religion, sex, national origin, ancestry, disability status, veteran status, sexual orientation, gender identity or expression, genetic information, marital status, citizenship status, or any other basis as protected by federal, state, or local law. Guerbet is committed to diversity, equity, and inclusion.

  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 or you can also call this number +19843443717

• About the company

  We are a global leader in medical imaging with products and solutions for diagnostic and interventional radiology.

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