Pharmacovigilance Specialist
hace 6 días
We are seeking an experienced Pharmacovigilance Specialist to join our team at Pharmalex. As a key member of our safety team, you will play a vital role in ensuring the safe use of pharmaceutical products.
Company Overview
Pharmalex is a leading service company for the Pharmaceutical Industry globally, specializing in all aspects of drug and medical device approval, market development, and product maintenance. We offer a dynamic work environment with daily new challenges and opportunities for growth.
Job Description:
- Management of safety-related information from various sources, including spontaneous reports, literature, clinical studies, and medical information enquiries.
- Case intake, translation into English, quality check, and documentation of cases in applicable trackers.
- Screening of local scientific literature for potential safety-relevant information.
- Support in creating Individual Case Safety Reports (ICSRs) for adverse events from clinical trials, spontaneous reporting systems, and literature.
- Reporting of ICSRs to local competent authorities based on national PV reporting requirements.
- Support in generating, processing, and tracking follow-up requests.
- Maintenance of PV trackers and preparation of monthly reconciliations for ICSRs.
Required Skills and Qualifications:
- Medical documentation specialist or degree in life sciences.
- Minimum 2 years of experience in pharmacovigilance.
- Attention to detail, quality, and timeliness in task completion.
- Professional verbal and written communication skills.
- Ability to work independently and as part of a team.
- Computer skills: MS Office, safety database, affinity for IT systems and tools.
Benefits:
- A competitive salary of €60,000 - €80,000 per year, depending on experience.
- The opportunity to work with a global leader in the Pharmaceutical Industry.
- A dynamic and supportive work environment.
- Ongoing training and professional development opportunities.
Language Requirements:
Fluent in German and English (spoken and written). Additional language skills such as French or Italian are beneficial but not required.
About Us:
Pharmalex is committed to providing a challenging and rewarding work environment that encourages personal and professional growth. If you are interested in this exciting opportunity, please submit your application documents stating your earliest possible starting date and any visa requirements.
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