Pharmacovigiliance Manager

Hungary · Full-time

About The Position

Medison is a global pharma company on a mission to help patients around the world get faster access to lifesaving, innovative, breakthrough therapies. We operate in 4 continents and over 24 countries and are growing fast. If you want to be part of our mission and help save patients by getting them the latest treatments, join us!

This role is a wonderful opportunity to join a newly formed regional PV team with key leadership responsibilities for all regulatory affairs and pharmacovigilance across a nominated cluster of countries within the CEE.  The role reports directly to the Director, Regulatory Affairs and Pharmacovigilence in CEE.

This position may be based in Czech Republic or Hungary

Responsibilities

Pharmacovigilence

  • Responsible for all pharmacovigilance activities on behalf of the MAH/distributor/importer in accordance with the local regulations and guidance in the countries assigned
  • Establishing and maintaining pharmacovigilance system and procedures covering all activities required by local regulations and safety agreements with manufacturers
  • First point of contact for local Health Authority and partners, communication with the regulatory authority regarding regulatory inquiries
  • Local literature review
  • Monitoring publications of the regulatory authority
  • Reconciliation with partners and internally
  • Monitoring and submission of safety signals to the regulatory authority
  • Performing and undergoing partner audits and regulatory inspection
  • Participating in training activities


Regulatory Affairs 

  • Assisting is MA registration process- communication with partners, preparation and submission of registration dossier for MA application, communication monitoring during the registration process until MA is obtained; variation management- submission, tracking of approval of all variations.
  • Assisting in renewal preparation- communication with partners and HA, submission. 
  • Preparation of the SmPC and PIL in local language as needed
  • Local regulatory requirements consultation
  • Preparation/submission of documentation to local HA for permission to supply in foreign pack
  • Preparation/submission of documentation to local HA for permission to relabel/repack
  • Key in role in liaising with and managing vendors and partners 
  • Plays key role in ensuring successful product launches following all local regulations and guidelines. 

Requirements

  • Degree in pharmacy or equivalent 
  • Requires an experienced at least 5-7  years experience in PV  in Pharma in at least one of the assigned countries. 
  • Candidate may have more experience in one or the other areas but a blend is ideal.
  • Ideally worked in Rare Diseases or Vaccines and understands the role of the virtual communication and working cross functionally and with external partners.
  • Highly collaborative and team spirited.
  • Patient centric 
  • Strong communication skills, verbally and in writing. 
  • Fluent English is essential
  • Excellent interpersonal skills and ability to successfully maintain professional and trusting relationship
  • Works effectively in highly dynamic and changing environments, displays agility and an incessant  communication behaviour curiosity.
  • Willing to travel internationally as needed to fulfil duties of the role.