We are growing, grow with us!
Are you looking for a dynamic company with daily new challenges and opportunities?
Then, Pharmalex is your career opportunity. Pharmalex is one of the leading service companies for the Pharmaceutical Industry globally and is specialized in all aspects of drugs and medical devices approval, of the market development and any action of effective product maintenance.
Specialist, Pharmacovigilance
Your Job
- Management of safety-related information from all sources (incl. but not limited to spontaneous, literature, clinical studies, medical information enquiries)
- Case intake (data entry), translation into English, quality check (without case assessment), documentation of the case in the applicable tracker(s)
- Screening of local scientific literature (safety relevant publications) and identification of potential safety-relevant information.
- Support with creation of Individual Case Safety Reports (ICSR) of adverse events deriving from clinical trials, spontaneous reporting systems and from the literature
- Reporting of ICSRs to local competent authorities, based on the national PV reporting requirements
- Support in the generation, processing and tracking of follow-up requests
- Preparation and management of monthly reconciliations for the ICSRs
- Maintenance of PV trackers
- Preparation of monthly reports
Your Profile
- Medical documentation specialist or degree in life-sciences
- Minimum 2 years of experience in the field of pharmacovigilance
- Orientation to details, quality and timeliness completion of tasks
- Professional verbal and written communication skills
- Confidence to work alone, as well as part of a team
- Ability to assimilate and analyze information rapidly
- Computer skills: MS Office, safety database, affinity for IT-systems and tools
- Flexibility and adaptability
- Self-confidence and assertiveness
- Fluent in German and English language (spoken, and in written form), further language skills like French, Italian would be beneficial
If you are interested in joining our Pharmalex team taking over this challenging job opportunity in our future-oriented company, we are looking forward to receive your application documents stating your earliest possible starting date, any visa requirements and salary expectations on-line.
Agencies only by prior agreement for the specific job opportunity.
