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Senior Drug Safety Specialist
2 mesi fa
Your key responsibilities will include:
* Ensuring the collection, management, reporting, and reconciliation of safety data in compliance with applicable legislation and client requirements.
* Performing quality control of safety data entered by the safety data manager.
* Reporting adverse events to regulatory authorities and ethic committees according to relevant regulations/laws.
* Distributing intra and inter-company serious and non-serious adverse reactions in agreement with client SOPs and PV agreements.
* Updating the PV archive with required documentation.
* Collaborating with the Senior Drug Safety Manager in the preparation of safety documentation, such as safety management plans, risk management plans, and periodic safety reports.
* Helping track compliance metrics.
* Collaborating in the drafting of internal working instructions and standard operating procedures.
To be successful in this role, you will need:
* A bachelor's degree in a scientific subject.
* 2+ years of experience in an equivalent role.
* A fluent level of English, with the ability to translate local spontaneous case reports in English.
* In-depth knowledge of the Life Sciences sector and Pharma.
In return, you will enjoy a competitive salary package, corporate bonus, individual commission scheme, and meal vouchers.
If you are a motivated and experienced professional looking for a new challenge, please apply now"}
