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.
Senior Pharmacovigilance Specialist
- Management of literature and/or case processing projects
- Safety management remits
- Screening scientific literature regarding safety relevant publications e.g. by using the internal search mechanism of Vigilit® and/or by making use of external tools and providers
- Creating search algorithms for literature screening
- Support with creation of Individual Case Safety Reports (ICSR) of adverse drug reactions deriving from clinical trials, spontaneous reporting systems and the literature; reporting of ICSRs to the competent authorities
- Documentation of case processing on a company and a case level
- Support in the generation, processing and tracking of follow-up requests
- Handling of Customer enquiries or complaints in the scope of Vigilit® and Vigicare® according to quality assurance requirements
- Assistance in the creation of periodic reports PSURs (Periodic Safety Update Reports), DSURs (Development Safety Update Reports), risk management plans and signal detection reports
- To assist in managing clinical trials
- Contact with clients (e.g. meetings, client visits, etc.)
- Translation Italian /English in the context of case processing
- Quality assurance remits
- To write/ review QA documents such as Working Instructions, SOPs, Working Procedures, templates, project metafiles etc. for PharmaLex pharmacovigilance projects
- To organise and perform training of the above mentioned QA documents
- To perform quality control tasks such as the Vigicare® quality check and other project-specific quality checks
- Preparation of and participation in internal and external audits/inspections
- University degree in Life Science
- Several years of experience in the field of pharmacovigilance
- Knowledge of relevant legislative and non-legislative guidelines on pharmacovigilance
- Knowledge of pertinent medical or pharmaceutical and clinical practice
- Detailed knowledge regarding project-related SOPs (internal and client-specific), global PharmaLex SOPs and pharmacovigilance related SOPs
- Ability to organise operating procedures and to take over project management duties
- Professional verbal and written communication skills with internal and external clients
- Fluent Italian and English skills
- Aim to regularly participate in internal and external professional training
- Excellent written and verbal communication skills
- Self-confidence and assertiveness
- Confidence to work alone as well as in a team
- Excellent knowledge of pertinent legislation / regulatory framework (GVP)
- Strategic, analytical and structured thinking
- Ability to assimilate and analyse information rapidly
- Ability to identify and offer solutions to problems in a pragmatic way
- Flexibility and adaptability
- Ability to adjust rapidly to new, unknown, challenging situations
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.