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Your role: A great opportunity has opened up in our pharmacovigilance team in Saudi Arabia . As a PV Associate and Qualified Person for Pharmacovigilance (QPPV) you will provide various office and location support activities. Identify, enhance and follow specific processes and procedures to maximize the efficiencies of the business to which the support is being provided; You will also ensure the correct functioning of facilities, office and/or business support services.
You will also be directly accountable for performing all Pharmacovigilance (PV) tasks allocated to the Local Patient Safety organizations under the supervision of the SSC Manager in a given SSC territory, which is Saudi Arabia. Tasks have to be performed in full compliance with all relevant global and local regulatory requirements and company standards and these tasks include:
Product safety surveillance which includes handling all local drug 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 (where applicable) and keeping product knowledge up-to-date to ensure appropriate Individual Case Safety Report (ICSR) handling
Reporting to local Health Authorities and Ethics Committees which includes timely submission of: expedited ICSRs to concerned local health authorities, cases to concerned local/central EC/IRBs, safety issue reports to concerned local health authorities and safety issue reports to concerned local/central EC/IRBs.
Compliance related activities including using applicable tools (e.g. IRT) to ensure local compliance in terms of ICSR handling according to local regulations and company timelines. Supporting the SSC Manager to ensure compliance reports to GPS via the applicable technical tool (e.g. SCCT) in a timely manner. Plus contributions to the Local PV file in close collaboration with Local PV Responsible (LPVR) persons to support completeness, accuracy and that relevant information is updated in a timely manner.
Tracking of clinical development and Patient Data Collection Systems (PDCS) activities in the assigned countries including supporting the SSC Manager that a complete overview on relevant local / global clinical studies and PDCS (ongoing and planned) in the local affiliates is kept. And supporting the SSC Manager that current global procedures for the handling of PDCS and clinical studies are followed.
The responsibilities also include Training activities such as completion of all mandatory PV trainings in a timely manner, Supporting PV training activities under the supervision of the SSC Manager and supporting the SSC Manager in PV related trainings as required.
Who you are:
• Pharmaceutical, healthcare background or relevant working experience with fluency in written and spoken Arabic and English
• Experience in in the pharmaceutical industry or health authority
• Good knowledge of local regulatory PV legislation and a good understanding of drug development and life-cycle management
• Strong team-working skills – working across cultural and functional boundaries, and participating ‘virtual teams’
• Good organizational skills, ability to prioritize work and adapt rapidly to changing priorities
• Position requires both domestic and international travel up to 10% of time.
What we offer: We empower you to fulfill 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!