Patient Safety Specialist
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.
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
- 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
- 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.