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.
- Management of safety-relevant information (level 1) from all sources (including, but not limited to spontaneous, literature, clinical studies, medical information enquiries)
- Case processing (data entry), including translation Portuguese/English and quality check of translation
- Data entry quality check (without case assessment).
- Screening of worldwide and local scientific literature (safety relevant publications), including creation of 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 from 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 literature surveillance and case processing, 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
- Translation Portuguese/English in the context of case processing and local literature screening, including quality checks of translations.
- Tests computerized systems according to validation procedures
- Perform quality control tasks such as project-specific quality checks
- Perform CAPA tracking and support CAPA management and implementation
- Support the Program Manager with all necessary information related to the specific project/program, as needed.
- Support for PVA management: data entry and maintenance of Client / PVA information in dedicated tracking toolSupport the preparation of responses to requests for information (safety requests) from regulatory authorities, health professionals, consumers, and others.
- Provide basic pharmacovigilance training to internal staff and Client’s personnel.
- Maintenance of iPHAsy database regarding the records related to the Client’s products portfolio.
- Insert and update the information of medicinal products in the extended EudraVigilance Medicinal Product Dictionary (xEVMPD).
- Medical Documentation specialist or University degree in Life Science
- Degree in Life Science or equivalent
- 0-2 years of experience in the field of pharmacovigilance
- Detailed knowledge regarding project-related SOPs (internal and client-specific), global PharmaLex SOPs and pharmacovigilance related SOPs
- Ability to organize operating procedures
- Professional verbal and written communication skills with internal and external clients
- Fluent in Portuguese and English
- Attention to detail and quality oriented working style
- Confidence to work alone as well as in a team
- Strategic, analytical and structured thinking
- Ability to assimilate and analyse information rapidly
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.