Life science graduate or equivalent qualification in pharmacy, nursing, or healthcare-related field.
At least 1 year of experience in pharmacovigilance.
Strong organizational skills with attention to detail and ability to multitask.
Effective management skills, particularly in time and issue management.
Advanced proficiency in English, both spoken and written.
Proficient in MS Office applications.
Responsibilities
Provide support to project team activities for clients and the company.
Process Individual Case Safety Reports (ICSRs) in compliance with regulations and client requirements.
Perform follow-ups on ICSR submissions.
Manage Serious Adverse Events (SAE) and Suspected Unexpected Serious Adverse Reactions (SUSAR) including unblinding and protocol reviews.
Handle product quality complaints and interact with Quality Assurance.
Engage in medical information interactions and coding using MedDRA and WHO standards.
Generate database outputs and reports for monthly client reporting.
Benefits
Training and career development opportunities.
Strong focus on personal and professional growth.
Friendly and supportive working environment.
Opportunity to collaborate with international colleagues, using English as the company language.
Full Job Description
Job Description
Providing support to other activities undertaken by the project team on behalf of the client and the company
Performing activities in the scope of ICSR management unit within agreed extent and timeframe (including, but not limited to):
Processing Individual Case Safety Reports (ICSRs) from all sources in compliance with applicable regulations, PrimeVigilance procedures and in accordance with client specific requirements and timelines
Product Quality Complaint handling and interaction with Quality Assurance
Medical Information interaction
MedDRA and WHO coding
Database Outputs and Reports (including data for monthly reporting to clients)
Workflow & resource management
Support of PV processes related to the ICSR management within PrimeVigilance and also to clients
More senior colleague may perform tasks assigned as per SOP to more junior position
Performing activities in the scope of ICSR management unit within agreed extent and timeframe
Supporting the RA & PV Network Department as needed, including acting as the LCPPV (Local Contact Person for Pharmacovigilance) for the specified country and taking on the role of PRLS (Person Responsible for Local Screening) for the designated language, as agreed with the line manager
Qualifications
Life science graduate, pharmacy, nursing, other healthcare related qualification or experience in pharmacovigilance
Minimum 1 year of work experience in pharmacovigilance
Organization skills, including attention to detail and multitasking
Management skills, including time and issue management
English - advanced (spoken, written)
Advanced literacy (MS Office)
Additional Information
We offer:
Training and career development opportunities internally
Strong emphasis on personal and professional growth
Friendly, supportive working environment
Opportunity to work with colleagues based all over the world, with English as the company language
