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Pharmacovigilance / Regulatory Manager

The National Responsible Person for Pharmacovigilance is responsible for ensuring that pharmacovigilance activities required for Belgium and Luxembourg are undertaken in line with the pharmacovigilance requirements of the company and applicable legislation. The responsibility applies for all Marketing Authorisations held in the country for the MAHs and where the MAH has pharmacovigilance agreements with third party MAHs. Local activities include the implementation of global and European procedures and the creation of local procedures, PV training for all local staff, compliance monitoring, reconciliation, and archiving of local pharmacovigilance and regulatory documentation. The role will also require do perform RA tasks and any other tasks assigned by the head of Pharmaceutical Affairs.

Job content

Reporting line to:      Head of Pharmaceutical Affairs Belgium/Lux

ACCOUNTABILITIES

  • Responsible Person for Pharmacovigilance (RPP)
  • Nominated as the local responsible person for pharmacovigilance with the national Competent Authority.
  • Ensure all CA and EMA pharmacovigilance communications received are forwarded to the QPPV and deputy QPPV.
  • Adequately manage, record and report all locally received product and medical enquiries, ICSRs and other safety information in close collaboration with GPVD.
  • Ensure compliance with the relevant global, EU and local SOPs
  • Ensure compliance with key performance indicators for ICSRs, PSURs, ACO’s, RMPs, RMM’s Safety variations and NCA requests and communications. Ensure Monthly Compliance Report is provided to EUPV.
  • Participate in Audits and Inspections and assist in CAPA management
  • Manage local Safety Data Exchange Agreements (SDEA)/Service Level Agreements
  • Local Literature and local social media screening
  • Periodic Reports (PSUR) and ACO reviews and oversight
  • RMP overview including monitoring Risk Minimization Measures (RMMs)
  • Competent Authority (CA): Ensure local CA websites and safety databases are screened on a weekly basis; ensure any CA requests are tracked and sent promptly to the QPPV and EUPV and adequately manage an oversight of proposed or competent authority require local studies.
  • SOP/WP and PV Training: Ensure all relevant local procedures are in place, create and share appropriately local SOP development plans. Ensure all local employees, contractors and distributors/service providers are trained according to local, EU and Global SOP’s.

 

WORKING RELATIONSHIPS

Internal:

  • Pharmacovigilance Department (EU & Global)
  • Local RA and Global RA
  • Local QA
  • Local Sales Group and other local functionalities

External

  • Healthcare professionals
  • Patients and Consumers
  • Local Competent Authorities

 

KNOWLEDGE AND EXPERIENCE

  • Life science knowledge with at least 3 years PV experience.
  • Recent experience in Pharmacovigilance (at least 3 years) in an affiliate setting
  • Knowledge of local and EU pharmacovigilance regulations, sound interest in worldwide pharmacovigilance regulations
  • Knowledge of Good Clinical Practice and Good Pharmacovigilance Practice
  • Good understanding of drug development and life-cycle management
  • Be process-orientated with a good level of attention to detail
  • Have a high level of computer literacy
  • Have excellent organisational skills with proven ability to cope with a wide variety of tasks and changing priorities
  • Excellent training and presentation skills
  • Excellent interpersonal and communication skills

 

 

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