Global Provider of Expert, High-Quality Services to the Biopharmaceutical Industry. Your Full-Service Solutions Partner.
Senior Pharmacovigilance Officer
Location
Poland
Posted
2 days ago
Salary
0
Seniority
Senior
Job Description
Senior Pharmacovigilance Officer
ERGOMED
• Processing of Individual Case Safety Reports from all sources (post-marketing and clinical trials, including device and combination products) in compliance with applicable regulations, PrimeVigilance procedures and in accordance with client specific requirements and timelines. • Independent SAE/SUSAR Management (submissions, unblinding, clinical trial reconciliations) • Preparation of database outputs for periodic reporting (PBRER, DSUR, PADER, etc.) • Mentoring and training of new and more junior employees within the department, including procedure optimization and development
Job Requirements
- Life science / bio medical background – healthcare related degree (chemistry, biology, biotechnology, veterinary science) and demonstrated experience in Pharmacovigilance case processing
- Demonstrated case processing experience
- Time and issue management, delegation, organization and multitasking skills with good attention to detail
- Strong interpersonal and communication skills
- Advanced English skills, both verbal and written, at least C1
Benefits
- 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
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Senior Pharmacovigilance Officer
ERGOMEDGlobal Provider of Expert, High-Quality Services to the Biopharmaceutical Industry. Your Full-Service Solutions Partner.
• Processing of Individual Case Safety Reports from all sources (post-marketing and clinical trials, including device and combination products) in compliance with applicable regulations, PrimeVigilance procedures and in accordance with client specific requirements and timelines. • Independent SAE/SUSAR Management (submissions, unblinding, clinical trial reconciliations) • Preparation of database outputs for periodic reporting (PBRER, DSUR, PADER, etc.) • Mentoring and training of new and more junior employees within the department, including procedure optimization and development
Senior Pharmacovigilance Officer
ERGOMEDGlobal Provider of Expert, High-Quality Services to the Biopharmaceutical Industry. Your Full-Service Solutions Partner.
• Processing of Individual Case Safety Reports from all sources (post-marketing and clinical trials, including device and combination products) in compliance with applicable regulations, PrimeVigilance procedures and in accordance with client specific requirements and timelines. • As a key member there is an expectation to effectively cover all steps of a workflow cycle, except Medical Review. • Independent SAE/SUSAR Management (submissions, unblinding, clinical trial reconciliations) • Preparation of database outputs for periodic reporting (PBRER, DSUR, PADER, etc.) • Mentoring and training of new and more junior employees within the department, including procedure optimization and development
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