Regulatory Specialist/PV Officer - Safety Reporting
- Full-time
- Department: Safety Reporting
Company Description
PrimeVigilance, an Ergomed company, was established in 2008 by former Drug Regulators, to provide specialised pharmacovigilance services to pharmaceutical and biotechnology companies. These services cover the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem (WHO definition of pharmacovigilance). Since then, PrimeVigilance has added other services including medical information call centres, and has grown to become one of the global leaders in its field, providing services to over 150 client companies in more than 100 countries. We continue to expand as we strive to become the leading global pharmacovigilance and medical information service provider. Our Mission is a world with safer drugs.
Job Description
Assurance and exertion of activities leading to effective cooperation with clients in the area of safety reporting
Support the client in all aspects of safety reporting
Performing submissions of ICSRs/aggregate reports to all concerned parties
Performing exchanges of ICSRs with all concerned parties as per applicable quality documents
Performing XEVMPD maintenance
Supporting the client with EudraVigilance registration and maintenance of EudraVigilance account
Support in all PV operations associated with Safety Reporting
Quality control of daily safety reporting activities
Active participation in trainings, maintenance and development of quality system documents for Safety Reporting area
More senior colleague may perform tasks assigned as per SOP to more junior position
Qualifications
Life science graduate, pharmacy, nursing or minimum 2 years of experience in Safety Reporting area
2-5 years of work experience in pharmacovigilance
Organization skills, including attention to detail and multitasking
Management skills, including time and issue management Communication skills
Presentation skills
Ability to motivate/coach people; leadership
English - advanced (spoken, written)
Additional Information
Our Offer
- Competitive salary
- Dynamic team of colleagues in a fast-growing company – possibility for your quick career growth
- Multicultural environment, English as a company language
- Strong emphasis on personal and professional growth
- Extensive and specialized trainings in pharmacovigilance – internal trainings provided by skilled professionals, but also prestigious trainings/seminars taking place abroad
- Friendly working environment with several social events per year