![Karo Healthcare](https://media.trabajo.org/img/noimg.jpg)
Global Patient Safety Data Specialist
8 hours ago
Karo Healthcare, a dynamic and growing company, empowers people to make intelligent health decisions.
As a Global Patient Safety Surveillance Specialist, you will play a crucial role in ensuring the safety of Karo's medicinal products. Your primary responsibilities will include:
- Having an overview of the medicinal product safety profiles and risk-benefit evaluations during its lifecycle.
- Ensuring all activities under your responsibility are fulfilled to high quality and in a timely manner within Safety Surveillance & Risk Management.
- Supporting EU & UK QPPV/deputy to maintain oversight of the PV system, particularly for Patient Safety surveillance activities.
- Providing aggregate data, writing, and reviewing reports such as PBRER, PSUR, DSUR, Addendum to Clinical Overview for Karo's medicinal products.
- Contributing to Risk Management Plans (RMPs) and risk minimization measures.
Requirements
To be successful in this role, you will need:
- A MSc. Pharm, Medicine, or equal master in life science.
- Minimum 3 years of Pharmacovigilance experience in the pharmaceutical industry.
- Experience in Aggregated Reports and Signal Management is highly merited.
- Fluent oral and written English communication skills.
- Expertise in MS Office (Microsoft Word, Excel, PowerPoint).
- Experience with Veeva Vault Safety.
- Knowledge of Pharmacovigilance Guidelines and Regulations.
What We Offer
We offer:
- Flexible schedule, hybrid model with the primary workplace in the office.
- Life-work balance.
- Responsibility for exciting and challenging projects that have a direct impact on our customers and the industry.
- A very positive work environment in a dynamic, international, and motivated team.
- Start-up spirit while being part of the large international organization with strong values.
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