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Global Patient Safety Surveillance Manager

Karo pharma/ Scientific solutions

08 sep

Smart choices for everyday healthcare

Karo Pharma offers a portfolio of everyday healthcare products and services that help prevent illness and treat health problems. With a wide range of trusted, documented, and original brands, backed by services for partners, customers, and consumers, we provide people with the options, knowledge, and access they need to stay healthy. We call it smart choices for everyday healthcare. We specialize in seven product categories: intimate health, dermatology, foot health; pain, cough and cold; wellness; digestive health and specialty products. Across these categories we own a range of differentiated brands in both prescription drugs (Rx) and consumer products (OTC).

Karo Pharma’s products and services are present in over 60 countries with own subsidiaries in over 11 European countries. Karo Pharma, with a revenue of SEK 2.9bn in 2020, is headquartered in Stockholm and listed on Nasdaq Stockholm.

Global Patient Safety Surveillance Manager
Karo Pharma is strengthening their Global Patient Safety and Medical Information department with a new position – Global Patient Safety Surveillance Manager. The position can be based at the headquarter in the heart of Stockholm, Sweden or at Karo Pharma’s office in Maidenhead, UK. You will report to the Global Patient Safety Team Lead/deputy EU & UK QPPV.

Roles and responsibilities:
Being the Global Patient Safety Surveillance Manager, you are committed to ensuring patient safety and product quality across the Karo Pharma portfolio. You will ensure a compliant Pharmacovigilance System for Safety Surveillance and Risk Management for Karo Pharma’s products. Additionally, you will play an important part in the building of a strong inhouse surveillance team that’s ahead in new data driven methods and approaches. You will also act as a scientific partner within Karo, collaborating with other functions such as brand teams, regulatory affairs, and safety physicians.

Main responsibilities:

  • Having an overview of the product safety profiles and risk-benefit evaluations during the full lifecycle.
  • Ensuring that the product information is kept up to date with the current scientific knowledge.
  • Ensuring scientific evaluation of risks of the Karo products.
  • Signal detection activities, involving identification, evaluation, analysis and interpretation of safety data for Karo products.
  • Ensuring the life-cycle benefit-risk safety profile of Karo’s medicinal products, including providing support to the Regulatory and Medical Affairs function during Reference Safety Information (RSI) (e.g. CCSI) review cycle.
  • Supporting the EU & UK QPPV/deputy to enable the QPPV to maintain oversight of the PV system in relation to Patient Safety surveillance activities.
  • Contributing to cross-functional initiatives aimed to improve pharmacovigilance capabilities related to signal detection (e.g. automatisation).
  • Developing the quality system in your own area of expertise, as per GVP requirement.
  • Supporting the local Medical Information set-up with product expertise from a medical perspective.

Qualifications and education:

  • Sc. Medicine, Pharm, or equal master in life science and 7 years of experience in Pharmacovigilance or equivalent, or Doctorate Degree and 5 years of experience from Pharmacovigilance
  • Fluent in oral and written English
  • In-depth knowledge of post market safety surveillance
  • In-depth knowledge of signal management in accordance to GVP Module IX, approx. 3 years of experience
  • Applicant must have a valid work permit to work in either Sweden or the United Kingdom
  • Good knowledge of Regulatory Affairs and life cycle management is an advantage

Personal Profile:

To be successful in this role, you have a genuine interest for patient safety and product surveillance, you can propose new ways of working, you are able to make decisions in a complex environment and you have a proactive approach to your work. Furthermore, you have a sense of structure and you can prioritise effectively to meet deadlines. Ideally, you can work independently but you also enjoy interacting with others and working as a team player.

We offer:

In return Karo Pharma will offer you an important role in a dynamic and international organization with great values and a sustainable profitable growth strategy. You will work with a team who share the interest to deliver on commitments and to have a positive work culture.

In this recruitment Karo Pharma partners with Scientific Solutions and all questions and applications will be managed by Scientific Solutions.

To apply, send your application by email to cv@scientificsolutions.se.

For further questions regarding the position, please contact: Anna Arnebrant, +46 73-995 56 25, anna.arnebrant@scientificsolutions.se

Welcome with your application as soon as possible and no later than Thursday 6th of October 2022. We are screening the applications on a running basis.

 

Karo Pharma 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.

Scientific Solutions specialises in talent supply for Life Science companies. We focus on management and specialist roles mainly within R&D, Clinical, Regulatory, Drug Safety, Sales and Marketing. www.scientificsolutions.se

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