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Senior Drug Safety Specialist

3 mesi fa

Lazio, Italia Arithmostech A tempo pieno

Via Squarcina, 13, Italy | Posted on 24/06/2024
Industry: Pharma/Biotech/Clinical Research
Work Experience: 1-3 years
City: Via Squarcina, 13
Country: Italy
Postal Code: 00141
Hybrid Job: Yes
About Us We are experts in the Life Sciences industry & Technology.
We are a long-standing partner for technology and expert service provider across Clinical, Regulatory, Quality, Pharmacovigilance and Medical Affairs domains.
We help companies to gain the best business value through technology-enabled solutions and achieve excellence in business operations.
Job Description We are currently looking for a Senior Drug Safety Specialist to join our team. The ideal candidate will manage the quality control of safety data supporting the Senior Drug Safety Manager in all PV activities such as the delivery of services to Clients in compliance with Regulatory Business Quality Standards.
Requirements Your Responsibilities:
Ensure the collection, management, reporting, and reconciliation of safety data, in compliance with the applicable legislation and according to Client requirements.
Perform Quality Control of safety data entered by the Safety Data Manager.
Report adverse events to Regulatory Authorities and Ethic Committees according to relevant regulations/laws.
Distribute intra and inter-company the Serious and Non-Serious Adverse Reactions in agreement with the Client SOPs and PV Agreements.
Update the PV archive with the required documentation.
Collaborate with the Senior Drug Safety Manager in the preparation of safety documentation (e.g. safety management plans, risk management plans, periodic safety reports etc.)
Collaborate in the drafting of internal Working Instructions and Standard Operating Procedures.
Your Background and Experience:
You hold a bachelor's degree in a Scientific Subject.
You have 2+ years of experience in an equivalent role.
A fluent level of English is a must. You will translate local (Italian) spontaneous case reports in English.
You have an in-depth knowledge in Life Science sector and Pharma.
In Arithmos we prioritize personal and professional growth, offering international opportunities for development and advancement. You'll have the chance to work on groundbreaking projects that significantly impact global healthcare outcomes, all while collaborating with leading experts in the field. Our flexible work policies support a healthy work-life balance. Our competitive compensation package is designed to acknowledge and reward your contributions:
Salary Package: from 25,000 to 30,000 euro.

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