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Job Description
- Assist the QPPV in maintaining a system which ensures that any emerging safety concern or adverse reactions is detected and reported to the PV department, in order to be evaluated and accessed and reported.
- Performing literature searches and obtaining literature articles and reviews, to guarantee up to date information.
- Preparation of adverse events and Adverse Drug Reactions in the appropriate format to the regulatory bodies, in compliance with the statutory timelines.
- Maintain an up to date knowledge of pharmacovigilance regulations.
- Organization of all cases into a comprehensive documentation system.
- Assist the QPPV in establishing a pharmacovigilance training program.
- Pharmacovigilance SOP writing and maintenance.
- Follow up, validation & assessment of ICSRs.
- Report writing using MedDRA coding.
- Monitoring of changes to the pharmacovigilance guidelines.
- Preparation of periodic safety update reports (PSURs).
- Preparation of risk management plan
- Follow-up of corrective and preventative actions under the supervision of the QPPV.
- DQPPV full dedicated for all QPPV tasks in his absence after communication and agreement
Job Requirements
- Holds a Degree of pharmacy or medicine
- 1-3 years of experience in Pharmacovigilance / Drug Safety / Medical Information
- Knowledge and familiarity with clinical trials
- Enthusiastic, motivated and with excellent communication skills
- Deals with confidential information and/or issues using discretion and judgment
- Advanced knowledge in applicable regulatory guidelines
- Ability to work with teams across different geographies and cultures
- Computer skills including proficiency in the use of Microsoft Word, Excel and PowerPoint.
- Scientific data analysis
- Strong written and verbal communication skills including good command of English
