Drug Safety Operations Specialist
4 weeks ago
Unicon Pharma Inc is seeking a highly skilled Drug Safety Operations Associate to join our team. As a key member of our Drug Safety Operations team, you will be responsible for performing adverse event processing responsibilities, supporting the Case Management function, and ensuring compliance with regulatory requirements.
Key Responsibilities
- Process and manage adverse event cases, including data entry, report distribution, and follow-up activities.
- Perform case triage, assessment, and coding using MedDRA, WHO-DRUG, and Company Product dictionaries.
- Support ICSR submissions and transmissions, and participate in inspections and audits as identified.
- Meet KPIs/KQIs as designated by the Client and in compliance with company guidelines and policies.
- Assist in writing late ICSR related deviations and CAPAs, upon request.
Requirements
- Bachelor's degree in life science or healthcare (e.g. nursing, pharmacy) with a minimum of 5 years of experience in a pharmaceutical/biopharmaceutical company.
- Minimum 3 years of experience in a Drug Safety Operations role, with experience overseeing CRO teams of case processors preferred.
- US FDA pharmacovigilance inspection experience preferred.
Necessary Skills and Abilities
- Resource and workflow management, including monitoring and assigning tasks.
- Up-to-date knowledge of US and international PV regulations and best practices.
- MedDRA coding and analytical skills.
- Strong negotiation and problem-solving skills, with attention to detail and accountability for deliverables.
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