Specialist, Pharmacovigilance Operations

Description

• Review, rank, verify, process and document case-related information: event terms; validity, seriousness, special scenarios; timelines; accuracy and consistency. Process cases based on these assessments
• Use source documents received to write a comprehensive narrative describing the adverse event appropriately
• Process safety data according to applicable regulations, guidelines, Standard Operating procedures (SOPs) and Company requirements.
• Contribute to the mentoring and training of new colleagues as needed.
• Support continuous improvement opportunities
• Support inspection readiness activities

Qualifications

• University degree in Pharmacy/Medicine or other relevant life sciences discipline (Dentistry, Experimental Medicine, Microbiology, Veterinary, Biotechnology, Physiotherapy, Medical Biology or similar)
• Minimum 1 year experience in drug safety/pharmacovigilance case processing
• Medical Writing experience preferred
• Argus safety database and other platforms MS Office suite, Excel, Powerpoint, Visio
• Effective time management skills
• Excellent communication skills (verbal and writing); results oriented and strong attention to detail
• Proficiency in English (verbal and/or written) required due to global collaboration needs