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Job Description
- For our various longstanding clients, audit project management and maintenance of a good client relationship will also be an important part of your work. Training clients’ staff on PV regulations or assist in inspection preparations may also be part of your role.,
- You may also be assigned as (deputy) QPPV to one or more clients. This concerns mainly smaller and medium-size companies, who often have a PV system under development or are undergoing major changes with (initial) marketing authorization applications. Your input as a PV expert is key to these clients, but in addition, we also consider (deputy) QPPV work experience a great asset to our auditors’ qualifications as they are through this role involved in all pharmacovigilance relevant processes and procedures of the client.
Main Job Tasks and Responsibilities:
- Provide high quality, balanced and timely information to requests for medical information from both internal and external customers.
- Maintain a database of Medical Information requests and responses.
- Develop and maintain current knowledge of products and disease states.
- Maintain references and other Medical Information resources.
- Receive and initially process product complaints; forward information to the Quality Assurance Manager.
- Prepare and conduct training for Sales and Marketing on company products.
- Review promotional material for adherence to advertising regulations and guidelines, and medical accuracy.
- Process adverse event information from clinical trials and spontaneous reports including clinical data entry into the electronic database.
- Ensure data accuracy, clinically valid case assessment, regulatory reporting status assessment, and follow-up is completed on pharmacovigilance cases.
- Report adverse events to the appropriate Regulatory Authorities, and clinical study personnel according to regulations and standard operating procedures.
- Maintain a log, compliance information and filing system for all pharmacovigilance cases.
- Provide pharmacovigilance training to internal staff, and external partners, as required.
- Actively participate in departmental and various cross-functional project teams that may include Regulatory, Sales and Marketing, and Medical Affairs.
- Participate in personal development and training sessions.
Job Requirements
- A University degree in Pharmacy is a must.
- 1 - 3 years’ experience in PV actual practice.
- Certification in Pharmacovigilance training is a must.
- Practical experience of preparation of PBRERs, ACOs, RMPs
- Practical experience of literature search, medical writing, quality monitoring of PV activities and in implementation of additional safety issues.
- Good User of MS office.
- Organized and Follow up.
- Negotiation, Problem solving and communication skills.
- Very good command of the English language.
