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Global Patient Safety- PV system manager

Karo Healthcare

09 feb

,

Scientific Affairs
Full time

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 M&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 (M&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 M&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 & 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 (M&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 & 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 plan)
  • Supports the development of digital tools for various PV activities including signal detection, schedules, and compliance, related to surveillance activities.
  • Identify and communicate potential safety issues to the QPPV and when applicable to the QP/RP
  • Performs other duties related to the position as necessary as defined in Standard Operating Procedures or as requested by leadership.
  • Contribute with own area of expertise during geo-expansion and acquisitions.
  • Continuous development in global and affiliate case processing and distribution
  • Contributing to the configuration of the safety database to meet new market needs.
  • Keeping QPPV function up-to-date concerning safety database and PV systems
  • Ensure that all activities are conducted to the highest ethical and safety standards in compliance with GVP and regulatory requirements (and GCP when applicable).
  • Provide expertise in activities in own areas of responsibilities and accountabilities, both within the Patient Safety department and associated external stakeholders.
  • Approving and updating controlling documents and records such as but not limited to procedures within own areas of responsibilities and accountabilities.
  • Negotiate and provide input to the ICSR Data transfer plan Karo and the Divestor as well as drive the progress of such agreements/Plans to meet stipulated deadlines.
  • Provide expertise in GVP IT in own areas of responsibilities and accountabilities, both within the Patient Safety department and associated external stakeholders.
  • Responsible for authoring or reviewing and approving; governing, controlling and compliance documents and records, such as but not limited to procedures within own areas of responsibilities and accountabilities.
  • Act as an SME in supporting and requesting evidence, evaluations, and documentation to ensure that deviations, CAPAs and CC are handled sufficiently.
  • Approving from a Business perspective, for example; validation impact assessment, release impact assessments

Requirements
Education Level:

  • Bachelor’s/master’s degree in bioinformatics or biotechnology (or equivalent), or other related degree such as MSc. Pharm, Medicine, or equal master in life science.

Work Experience:

  • Pharma industry experience and experience from working with GxP systems and specifically GVP, and computer compliance.
  • Minimum 3 years’ experience from pharmacovigilance; global case processing, safety system out-puts.

Other merits of relevance:

  • Fluent in oral and written English
  • Expert in Microsoft Word, Excel, PowerPoint.
  • safety database management
  • Safety database maintenance such as report generations (desired, not mandatory)

Merit:

  • Headquarters (HQ) level experience
  • Working with safety databases from case processing and IT perspective

Personal characteristics:

  • Analytic mindset
  • Enjoy solving problems and mediating issues that may arise and the ability to propose new and more efficient ways of work.
  • Structural sense and excellent attention to detail and accuracy, maintaining consistently high-quality standards
  • Ability to make decisions in a complex environment.
  • Able to prioritise effectively and meet multiple deadlines successfully
  • Maintaining a good relationship with concerned stakeholders in cross-functional processes.
  • Enjoying a dynamic and multitasking business environment
  • Comfortable in raising objections and reason for your position in a constructive way
  • Able to work effectively both independently and collaboratively across the organisation
  • Problem-solving attitude and the ability to successfully execute in a dynamic environment
  • Show strong evidence of our Karo values

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 a 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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