Patient Safety Manager Position

14 hours ago


Stockholm, Stockholm, Sweden TN Sweden Full time
Role Summary:
The Global Patient Safety Surveillance Specialist plays a critical role in ensuring the safety of medicinal products throughout their lifecycle. This involves reviewing product safety profiles, risk-benefit evaluations, and aggregate data. The successful candidate will also support EU & UK QPPV/deputy, enabling them to maintain oversight of the PV system. Additionally, they will contribute to the development of Risk Management Plans (RMPs) and provide input on signal detection & validation activities.

Key Responsibilities:
Review product safety profiles and risk-benefit evaluations
Ensure all activities under own responsibility are fulfilled to high quality and in a timely manner within Safety Surveillance & Risk Management
Support EU & UK QPPV/deputy in maintaining oversight of the PV system
Contribute to the development of Risk Management Plans (RMPs)
Provide input on signal detection & validation activities
Support the development of Company Core Safety Information (CCSI) management

Requirements:
MSc. Pharm, Medicine, or equivalent master's degree in life science
Minimum 3 years of Pharmacovigilance experience in the pharmaceutical industry
Fluency in oral and written English
Expertise in MS Office
Knowledge of Pharmacovigilance Guidelines and Regulations

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