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.
- Individual Case Safety Report (ICSR) assessment of adverse drug reactions deriving from spontaneous reporting systems and the literature; decision on expedited reporting; reporting of ICSRs to the competent authorities
- QC, including case assessment.
- Preparation and review of Clinical Expert Statements
- Communication with regulatory authorities and client companies regarding all pharmacovigilance-focused aspects
- Evaluation of the benefit-risk profile of drugs based on current scientific knowledge - this includes the creation of safety update reports PSURs (Periodic Safety Update Reports) and associated documents such as AdCOs (Addendum to the Clinical Overview), DSUR (Development Safety Update Reports), risk management plans and signal detection reports
- Writing/Review of procedural documents such as Working Instructions, SOPs, Working Procedures, Templates etc. for PharmaLex PV projects
- Organize and perform training of the above-mentioned procedural documents
- Preparation of and participation in internal and external PV audits/inspections.
- CAPA generation, review and approval.
- Support the Program Manager with all necessary information related to the specific project/program, as needed.
- Project management.
- Preparation and maintenance of Pharmacovigilance System Master Files (PSMFs), including review.
- PVA management: creation/negotiation, review, update and implementation of PVAs in dedicated tracking tool
- Review of PV Intelligence Reports and perform gap analysis/impact assessment on own processes.
- Preparation of responses to requests for information (safety requests) from regulatory authorities, health professionals, consumers, and others.
- Oversee maintenance of iPHAsy database regarding the records related to the Client’s products portfolio.
- Coordination of the process to update the information of medicinal products in the extended EudraVigilance Medicinal Product Dictionary (xEVMPD);
- Training of staff in selected areas of pharmacology as well as training in safety-relevant aspects related to the use of medicinal products. In addition, contents in the field of development, production, examination and storage of medicinal products are provided
- Follow-up of scientific and regulatory development especially concerning the topic pharmacovigilance and passing on relevant information to PharmaLex employees and clients
- Education and training of pharmacists or pharmaceutical trainees as well as other health care professionals
- Degree in Natural Science or equivalent and ideally also a doctorate degree
- Excellent knowledge of relevant legislative and non-legislative guidelines on pharmacovigilance
- 3-5 years of experience within the field of pharmacovigilance (all areas of pharmacovigilance and not limited to case management).
- Reside in Portugal
- Ability to organize operating procedures and to take over project management duties
- General knowledge of pertinent medical or pharmaceutical issues
- Detailed knowledge regarding project-related SOPs (internal and client-specific), global PharmaLex SOPs and pharmacovigilance related SOPs
- Fluent in Portuguese and English
- Professional verbal and written communication skills with internal and external clients
- Aim to regularly participate in internal and external professional training
- Autonomous, concentrated and high-quality work
- Ability to work in a team
- Sense of responsibility
- Strategic, analytical and structured thinking
- Ability to assimilate and analyse information rapidly
- 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.