Patient Safety Specialist

Regulatory Affairs/Clinical Affairs Nazareth, Belgium


Descripción

Perrigo Company is dedicated to making lives better by bringing high quality and affordable self-care products that consumers trust everywhere they are sold.  Help us do it.

We are excited to be currently looking for a Patient Safety Specialist to join the CSCI Global Patient Safety team based in Nazareth, Belgium. This position, reporting to the Manager of PV Ops & QPPV Office will become a valuable member of the Global team. This position is envisaged to be a hybrid role, encompassing a number of QPPV related tasks alongside Safety Writing responsibilities.

Responsibilities

QPPV office Tasks:

  • Follows-up and presents inspection and global PV audit deliverables and corrective preventive
  • actions (CAPA)
  • Communication with external PV partners
  • Participating on PV audits, inspections
  • Preparing PV audits, inspections
  • Assist with process, tools and tracking mechanism for Perrigo departmental deviations
  • Ensuring that all Pharmacovigilance activities are conducted in accordance with internal
  • SOP’s/WIs, Good Pharmacovigilance Practice guidelines and regulatory requirements.
  • Working as part of QPPV office to ensure inspection readiness, ensuring compliance with SOP’s
  • and regulatory standards.
  • Creating, maintaining and reviewing of all PV SOPs and WI
  • Setting up & preparing meeting minutes during PV debriefing/PV meetings
  • Performing PV trainings
  • Creating training material
  • Keeping company profile up-to-date on Eudravigilance
  • Collaborate with management to achieve the objectives of the Department.
  • Perform ad hoc duties & projects as assigned.
  • Support local PV initiated projects with Local PV contacts
  • Coordinate PV questionnaire with affiliates in relation to medicinal products and local PhV
  • activities ensuring appropriate questions developed for the relevant PhV purpose

Safety Writing:

  • You will collect the required data for the authoring of Safety documents.
  • You will document, write, coordinate, review and validate periodic reports such as PBRER, RMP,
  • ACO and other related safety documents.
  • You ensure generation, consistency, and quality of safety sections in submission documents.
  • Assist in creations of core structured benefit-risk assessments, core Risk Management Plans
  • (RMPs), and EU RMPs.
  • Develops and maintains respective standards and Calendars for PSURs
  • Supports inspection and audit activities with regards to the BRE processes
  • implementation/development/update of CDS/CSI for Perrigo medicines portfolio

 

Requirements:

  • Life science degree or equivalent through experience.
  • You have at least 1 TO 2 years of significant and successful experience in Pharmacovigilance
  • Highly analytical, process minded and detail oriented.
  • Be able to work in a matrix environment whilst remaining organized at all times.
  • You demonstrate initiative and capacity to work under pressure.
  • You have a hands on-mentality and a proactive attitude.
  • You are fluent in English and have excellent communication skills. Knowledge of other European languages is an asset.
  • You are a true team player and demonstrate leadership within cross-functional team environment

We're proud to be an equal opportunity employer- and celebrate our employees' differences, regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, or Veteran status. Different makes us better.