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PSMF and PVA Manager

Karo Healthcare

09 feb

,

Scientific Affairs
Full time

Description
Karo Healthcare, a dynamic and growing company, is all about making smart choices for everyday healthcare. With a wide-ranging portfolio across seven categories including medical products, we own and sell over 100 brands in about 90 countries. Our portfolio includes such brands as E45, Pevaryl, Lamisil, Nutravita, Decubal and many others. Our core belief in empowering people to make intelligent health decisions drives our growth strategy, blending organic expansion and M&A. Since 2019, under EQT ownership, we’re rapidly heading towards a €1 billion European leadership position in consumer health.

Join us at Karo Healthcare on our exciting journey. We’re currently looking for a PSMF and PVA Manager for our office in Stockholm.

Aim of the job:
You would lead the preparation of all the Karo applicable Pharmacovigilance System Master Files (PSMFs) and Summaries of Karo’s PV System by the assigned schedule and applicable laws, regulations and guidelines to ensure a compliant and updated description of the PV system

Ensure oversight and coordination of PVAs including PVA tracker maintenance & oversight, following PVAs and in compliance with applicable processes.

Tasks and responsibilities
PSMF Manager:

  • Maintain the PSMF Core and Annexes up to date by applicable procedures and timelines and ensure that it is possible to gain assurance that; the PV system has been implemented per the requirements, obtain the overview of the compliance and any deficiencies in the PV system, including information about risks or actual failure in the conduct of specific aspects of PV
  • When necessary revise to take account of experience gained, technical and scientific progress and amendments to the legislative requirements
  • Ensure that the PSMF is legible, complete, succinct, and accurate and reflects the current PV system in place and provided in a manner that ensures all documentation is accessible and allows full traceability of changes
  • Liaise with key contributors to ensure content is provided promptly, collating the data and circulating it for review as appropriate
  • Responsible for the PSMF maintenance process including setting up new routines or enhancing the processes as needed
  • Ensure that appropriate quality and compliance measures are met concerning the PSMF.
  • Responsible for timely maintenance of the Source document to Annex H and the Product List to the Summary of the PV system as triggered by monitoring of the PSMF mailbox.
  • Supporting in providing compliance data for Annex F with regards to GVP training in LMS
  • Supporting in providing up-to-date information on digital media for maintenance of Annex C
  • Ensure QPPV escalation of KPI non-compliance in connection to Annex F updates
  • Ensure the completed PSMF and Summary of the PV system and contributing documentation are archived appropriately.
  • Keeping up to date about changes to the global pharmacovigilance legislation with regard to own area of responsibility

PVA Manager:

  • Supportive in the PVA maintenance process e.g. establishing new routines or enhancing the processes as needed
  • Supporting the GPS team with the preparation of Pharmacovigilance Agreements (PVAs)/Safety Data Exchange Agreement templates
  • Ensure oversight and coordination of PVAs trackers maintenance & oversight, in accordance with PVAs and compliance with applicable processes.
  • Ensuring and monitoring the PVA KPIs
  • Escalating to the GPS team whenever a revision date for a PVA is emerging
  • Providing PVA-related up-to-date data for inclusion in the PSMF (e.g. Annex F, Annex B)
  • Ensuring appropriate archiving of PVAs

Requirements

  • MSc. Pharm, Medicine, or equal master in life science.
  • Minimum 4 years experience in pharmacovigilance.
  • Working at a global Pharmacovigilance department
  • Working with PSMF maintenance
  • Working with PVA management
  • Fluent in oral and written English
  • Profound skills in Microsoft Word, Excel, PowerPoint.

Benefits

  • Opportunity to create, grow, and encourage
  • Apart from a competitive salary pack, there are lots of growth opportunities to meet your personal ambitions
  • Flexible schedule and life work balance
  • Responsibility for exciting and challenging projects that have a direct, visible impact on our customers and the industry
  • Very positive work environment in a young, international, and motivated team
  • Start-up spirit while being a part of the large international organization with strong values

Karo Healthcare has a Diverse & Inclusive environment. We are looking for qualified candidates irrespective of gender, gender identity, sexual orientation, ethnicity, race, religion, national origin, disability or age.

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