Global Patient Safety- PV system manager
Karo Healthcare, Sweden
Job Description
Karo is at an exciting stage in its journey to become a 1 billion European leader in consumer healthcare.
Our purpose is to deliver better everyday health through smart choices and after a series of exciting acquisitions, we now own a strong portfolio of consumer healthcare brands, including E45, Decubal, Nailner, CCS, Multi-Gyn, Flux, Paracet, Alpha Foods, Remescar and Nutravita across Global markets.
Alongside a continued active Mamp;A agenda, our target is to accelerate the growth of our current brand portfolio, growing 7-10% CAGR over the next 3 years. For our priority brands, this means double-digit growth, equating to growth well ahead of the category. To achieve this, we must serve consumers better than the competition and for Karo, this requires a transformation in how we build our brands, innovate and go to market.
Take the lead in driving the Global Patient Safety (GPS) digital strategy and agenda within mergers and acquisitions (Mamp;A) and divestments, global case processing and surveillance, with the aim to deliver efficiency, quality, and compliance with worldwide PV regulations.
As part of our GPS Operations and Mamp;A Team ensuring GPS business needs are considered for Karo’s safety database and other PV systems.
Collaborate cross-functionally across Karo with different functions, including but not limited to:
- Nominated safety project amp; integration lead
- Digital Operations Strategy and Compliance
- Application Support Team
- Surveillance Team
- Global Case Processing Team
- GPS Compliance, Processes and Project Team
- Regulatory Affairs
to better understand business needs and provide data-driven insights and recommendations.
To administrate a compliant safety database system of the Marketing Authorisation Holder (MAH) Karo. To ensure that appropriate quality and compliance is met with regards to pharmacovigilance (PV).
As a Subject Matter Expert have oversight, assure compliance, and maintain (author or review) certain parts of the global Quality Management system, such as:
- Procedures related to safety database management
- Change control management of systems to assure continuous compliance of the PV system, products and PSMF.
The responsibilities comprise, but are not limited to the below, either as part of the individual job description or the responsibility and project lead for external resources:
- Providing the QPPV function with safety database oversight; including updates on the validation status of the database, any failures that occurred during validation and the corrective actions that have been taken to address the failures; information of significant changes that are made to the database (e.g. changes that could have an impact on pharmacovigilance activities).
- From a business governance perspective, handle the Release Management in Veeva Vault Safety related to product enhancements, bug fixes and new features.
- Driving the digitalisation and automatization of case processing, reporting and distribution as well as surveillance activities in Veeva Vault Safety, in accordance with applicable legislation
- Overseeing, driving, and executing on the safety data migration for Karo mergers, acquisitions (Mamp;A) and divestment projects from a PV Business perspective.
- Act as PV Business user for Veeva Vault Safety
- Ensuring all activities under own responsibility are in compliance with Karo SOPs, PV legislation and GVP requirements.
- Developing the quality system in own area of expertise, as per GVP requirement.
- Ensuring all activities under own responsibility within Safety database and with 3rd partners with whom Karo hold a Safety Data Exchange Agreements (SDEA)/ Pharmacovigilance Agreement (PVA).
- Exploring/developing opportunities to integrate with digital solution in other part of the Karo business, such as Scientific Affairs; Regulatory amp; QA
- Taking part and contributing to oversight and control of the PV system, including compliance to processes and system requirements
- Reviewing with regards to; quality, accuracy and when applicable, quality approval of Deviations and CAPAs
- Issuing, reviewing, and approving the governing, controlling and compliance documents and records, within own areas of responsibilities and accountabilities, consistent with the global PV Quality System
Tasks:
- Review Veeva Release notes and make strategic decisions on available configurations
- Approve Release Management Analysis
- Overseeing and leading the generation of various Veeva Vault Safety outputs, e.g. line listings, tabulations, and reports
- Leading the transfer of global safety database/data migration for new acquisitions (infrastructure integration and migration pl