A career at our company is an ongoing journey of discovery: our around 56,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others.
The Role is responsible for ensuring company compliance with pharmaceutical regulations and laws as well as providing expertise on drug safety and medical topics.
Provides safety expertise to clinical development programs.
Performs pharmacovigilance with rapid identification and analysis of safety signals, to define emerging drug safety profiles of products and drive patient risk management.
Provides various office and location support activities. Identifies, enhances and follows specific processes and procedures to maximize the efficiencies of the business to which the support is being provided; ensures the correct functioning of facilities, office and/or business support services. The role is directly accountable for performing all pharmacovigilance (PV) tasks allocated to the Local Patient Safety organization under the supervision of the Local Patient Safety Officer (LPSO) in a given country/territory. Tasks have to be performed in full compliance with all relevant global and local regulatory requirements and company standards. This includes but not limited to:
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 andnon-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
• Performing screening of relevant local health authority web sites 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 timelymanner, 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 LPSO
2. Reporting to local Health Authorities and Ethics Committees
• Timely submission of expedited ICSRs to concerned local health authorities (where applicable)
• Support of e-reporting in e-reporting ready countries (where applicable)
• 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 (e.g. IRT) to ensure local compliance in terms of ICSR handling according to local regulations and company timelines
• Supporting the LPSO to ensure compliance reports to GPS via the applicable technical tool (e.g. SCCT) in a timely manner
• Contributions to the Local PV file in close collaboration with cross-functions 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 LPSO that a complete overview on local / global clinical studies and PDCS (planned as well as ongoing) in the local affiliate is kept
• Supporting the LPSO that current global procedures for the handling of PDCS and clinical studies are followed
5. Training activities
• Completion of all mandatory PV trainings in a timely manner
• Supporting PV training activities under the supervision of the LPSO
• Supporting the LPSO in PV related trainings as required
6. Include additional responsibilities as per local requirement
7. Deputy functions (e.g. Deputy for LPSO)
Who you are:
- Medical, pharmaceutical or health care background or relevant working experience• Fluent in written and spoken local language and English
- Experience in in the pharmaceutical industry or health authority (thereof 2-3 years in patient safety)• Good knowledge of local 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
Functional area: Regulatory & Medical Affairs
What we offer: With us, there are always opportunities to break new ground. We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!
Curious? Apply and find more information at https://jobs.vibrantm.com