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 Specialist Pharmacovigilance
- 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 & local scientific literature (safety relevant publications), including creation of search algorithms for literature screening
- Performing administrative and operative tasks within iPHAsy and iPharSearch (literature surveillance tools) such as management of user accounts and validation of search criteria and strategy
- Coordination of Worldwide and Local Literature activities developed at a local level
- Tracking of the internal literature ordering process
- 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
- Assist Manager Pharmacovigilance in managing clinical trials
- Contact with clients (e.g. meetings, client visits, etc.)
- Translation Portuguese/English in the context of case processing and local literature screening, including quality checks of translations.
- Test computerized systems according to validation procedures
- Author/review procedural documents such as Working Instructions, SOPs, Working Procedures, templates etc. for PharmaLex pharmacovigilance projects
- Organize and perform training of the above mentioned procedural documents
- Perform quality control tasks such as project-specific quality checks
- Preparation of and participation in internal and external PV audits/inspections
- Ensure implementation and management of Corrective and Preventive Actions (CAPA) for own processes, including tracking of CAPA status.
- Support the Regulatory/PV Intelligence screens of the applicable sources (e.g. Authority websites) and alignment with (Senior) Manager PV on gap analysis/impact assessment.
- Support the Program Manager with all necessary information related to the specific project/program, as needed.
- Project management pertaining to local projects/ clients.
- Support the QPPV/GPO with all necessary information related to the specific project/program, including extraction and compilation of applicable data and information for the PSMF.
- Assistance to the preparation and maintenance of Pharmacovigilance System Master Files (PSMFs).
- Support for PVA management: data entry and maintenance of Client / PVA information in dedicated tracking tool
- Support 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); Support coordination of activity.
- Medical Documentation specialist or University degree in Life Science
- Degree in Life Science or equivalent with proven expertise and experience in GxP and / or pharmacovigilance (GVP) and related aspects
- At least 2 years of experience in the field of pharmacovigilance
- Excellent knowledge of relevant legislative and non-legislative guidelines on pharmacovigilance
- Detailed knowledge regarding project-related SOPs (internal and client-specific), global PharmaLex SOPs and pharmacovigilance related SOPs
- Ability to organize operating procedures and to take over project management duties
- Professional verbal and written communication skills with internal and external clients
- Fluent in Portuguese and English
- Excellent written and verbal communication skills
- Attention to detail and quality oriented working style
- 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.