For a pharmaceutical company located South-East of Brussels, we are looking for a PV consultant.
- Are you looking for a parttime position in drug safety?
- Are you trilingual?
- Do you have experience in patient safety?
Then this is a unique opportunity for you! Please contact me for further information!
He/she is directly accountable for performing all Pharmacovigilance (PV) tasks allocated to the Local Patient Safety organizations under the supervision of the Safety Manager in BENELUX. Tasks have to be performed in full compliance with all relevant global and local regulatory requirements and company standards.
1.Product safety surveillance
- Handling of all local safety information, including collection, registration, translation from local language into English, and transmission to GPS as applicable in a timely manner
- Seeking comprehensive initial and follow-up information on Individual Case Safety Reports (ICSRs) from all relevant spontaneous sources, and (where applicable) of cases from local interventional and non-interventional studies, Patient Data Collection Systems (PDCS) and quality complaints that are combined with adverse event information in a timely manner
- Performing screening of relevant local medical/scientific literature in accordance with GPS procedures and local requirements (partially outsourced)
- Performing screening of relevant local health authority websites according to global standards as defined by relevant quality documents
- Collaboration with medical information, quality assurance, complaint management and PDCSs to ensure safety reporting procedures are in place, safety relevant information is processed in a timely manner, and reconciliation is completed
- Keeping product knowledge up-to-date to ensure appropriate Individual Case Safety Report (ICSR) handling
- Performing required safety activities in the absence of the SC Manager
2.Reporting to local Health Authorities and Ethics Committees
- Timely submission of expedited cases to concerned local/central EC/IRBs as applicable
- Timely submission of safety issue reports to concerned local health authorities
- Timely submission of safety issue reports to concerned local/central EC/IRBs as applicable
3.Compliance related activities
- Using applicable tools to ensure local compliance in terms of ICSR handling according to local regulations and company timelines
- Supporting the SC Manager to ensure compliance reports to GPS via the applicable technical tool in a timely manner
- Contributions to the Local PV file in close collaboration to support completeness, accuracy and that relevant information is updated in a timely manner
4.Tracking of clinical development and Patient Data Collection Systems (PDCS) activities in the assigned countries
- Supporting the SC Manager that a complete overview on relevant local / global clinical studies and PDCS (ongoing and planned) in the local affiliates is kept
- Supporting the SC Manager that current global procedures for the handling of PDCS and clinical studies are followed
- Completion of all mandatory PV training in a timely manner
- Supporting PV training activities under the supervision of the Manager
- Supporting the Manager in PV related training as required
- Medical, pharmaceutical, healthcare background or relevant working experience
- Fluent in written and spoken local languages and English
- Experience in the pharmaceutical industry or health authority (thereof min 3 years in patient safety)
- Good knowledge of local (Belgium and Luxembourg) regulatory PV legislation
- Good understanding of drug development and life-cycle management
- Strong intercultural skills (developed from practical experience)
- Strong team-working skills – working across cultural and functional boundaries, and participating ‘virtual teams’
- Good problem-solving and decision-making ability
- Good organizational skills, ability to prioritize work and adapt rapidly to changing priorities
- Ability to manage multiple situations/issues under time pressure
- Effective presentation and training skills
015 21 11 04