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.
Clinical Safety Senior Specialist
Locations: Portugal, Spain, and Bulgaria
- Provide support to Clinical Safety Leads (CSLs)/managers and act as their back-up in specific situations.
- Oversight of activities performed by Junior specialists
- Training safety specialists / Overview of SAE process handled by junior specialists.
- Support Safety Manager with Review of cases in safety database (QC)
- DSUR support with some sections and DSUR submission
- SUSAR management
- SUSAR submission
- Maintaining SUSAR trackers for every project
- Maintaining LL trackers for every project
- Maintaining annual plans for LLs / DSURs and distribution lists.
- Monthly updates on local requirements from Regulatory Authorities/Ethic Committees
- Successful completion of a Bachelor’s degree in medical, natural sciences or pharmacy-related field or Degree in Medicine
- Good knowledge of clinical trial PV legislation (at least in EU) and in Good Clinical Practices
- At least 1 year of relevant professional experience in the field of Pharmacovigilance.
- Knowledge of safety databases (Argus, Safety Easy are preferred)
- Experience in case management activities
- Previous experience in pre-authorisation area.
- Team-oriented approach
- Organizational skills, ability to multi-task. Ability to assimilate and analyse information rapidly.
- High sense of responsibility and self-motivation
- Highly service-oriented
- Flexibility and adaptability to adjust rapidly to new, unknown, challenging situations.
- Fluent written and spoken English skills.
- Excellent written and verbal communication skills.
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.