Medicine Safety Analyst

17 hours ago

Stockholm, Stockholm, Sweden Karo Healthcare Full time
Overview

Karo Healthcare is committed to delivering innovative solutions that improve patient outcomes and enhance the quality of life. Our core mission is to empower people to make intelligent health decisions, driving our growth strategy by blending organic expansion and M&A.

With a wide-ranging portfolio across seven categories, we own and sell over 80 brands in about 90 countries. We believe in creating a dynamic and inclusive work environment that fosters growth and encourages collaboration.

Job Description

We are seeking a skilled Medicine Safety Analyst to join our team at Karo Healthcare. As a key member of our Pharmacovigilance department, you will be responsible for ensuring the safety of our medicinal products.

Key Responsibilities:

  • Overseeing the safety profiles and risk-benefit evaluations of our medicinal products during their lifecycle.
  • Fulfilling activities under your responsibility to high quality and in a timely manner within Safety Surveillance & Risk Management.
  • Ensuring all activities under your responsibility within Safety Surveillance & Risk Management for Karo products and with 3rd partners with whom Karo hold a Safety Data Exchange Agreements (SDEA)/Pharmacovigilance Agreement (PVA).

You will work closely with our EU & UK QPPV/deputy to maintain oversight of the PV system, particularly for Patient Safety surveillance activities.

Your tasks will include providing aggregate data, writing and reviewing reports such as PBRER, PSUR, DSUR, Addendum to Clinical overview, for Karo's medicinal products. You will also contribute to the development of Risk Management Plans (RMPs) and any risk minimisation measures.

You will perform signal validation and further signal assessment activities as applicable, and contribute to the Company Core Safety Information (CCSI) management. Additionally, you will bring suspected safety concerns to the Safety Review Board and present signal detection & validation activities to the board.

This role requires a strong background in Pharmacovigilance and experience in Signal Management. You should have excellent communication skills and be able to work effectively in a dynamic environment.

Requirements

  • MSc. Pharm, Medicine, or equal master in life science.
  • Minimum 3 years of Pharmacovigilance (post-marketing) experience in the pharmaceutical industry.
  • Experience in Aggregated Reports and Signal Management merits.
  • Fluent in oral and written English.
  • Expert in MS Office (Microsoft Word, Excel, PowerPoint).
  • Experience of Veeva Vault Safety.
  • Knowledge of Pharmacovigilance Guidelines and Regulations.
  • Enjoying a dynamic and multitasking business environment.
  • Strong structural sense (project planning skills) and organisational abilities, prioritisation, and time management proficiencies.
  • Attention to details and accuracy, maintaining consistently high-quality standards.
  • Able to work effectively both independently (limited supervision) and collaboratively across the organisation.
  • Able to identify and implement process and/or application improvements.
  • Problem-solving attitude and the ability to successfully execute in a dynamic environment.
  • Show strong evidence of our Karo value.

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, hybrid model with the primary work place in the office, 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 dynamic, international, and motivated team.
  • Start-up spirit while being a part of the large international organization with strong values.

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