Are you a data officer with experience and would you like to share your knowledge? This is your chance!
In this job you are responsible for maintenance of excellence in Regional PV Process Data Assurance/Medical Consistency. You reports to
the Regional PV Process Data Assurance/Medical Consistency Lead and contributes to the implementation, and
successful execution of the GPV objectives, supporting the overall GPV mission. You works extensively with vendor personnel and PV process staff within the region to ensure the high data quality required to support the ongoing assurance of the safety profile of products and compliance.
You ensure and maintain excellence, consistency, completeness, and accuracy in case processing within region by performing quality control for outsourced activities and you collaborate with global vendor managers to ensure capacity management of global case flow in order to maintain critical business continuity in all circumstances.
You are responsible for:
- ensuring the quality of contracted work delivered under the GPV Process Management office;
- execution of all in-house case processing activities on time and with high quality to ensure compliance with regulatory requirements and policies;
- operational execution of ICSR processing and evaluation in assigned region (Data collection, Triage,
Translation, Data entry, MedDRA coding, Case Assessment & Medical Evaluation, and Follow-up) in line with
global ICSR case processing policies and strategies;
- first line decision making on case processing matters for priortization, FU significance, seriousness,
listedness, coding queries, etc.;
- performing SME services for ICSR processing queries by the vendor / internal case processing staff;
- training (PV Processes and Systems) of Vendor and PV Process staff in assigned region;
- the development and maintenance of effective collaborations with internal GPV stakeholders and functions, as well as of relevant external stakeholders;
- operational execution of QC of ICSRs, including at vendor level in assigned region.
To qualify for this position:
- You have a MS degree in life sciences or equivalent;
- You have more than five years relevant experience;
- You have In-depth knowledge and understanding of PV Process regulatory requirements and ICSR processing procedures globally and in assigned region;
- You are a technical expert within the organization, with extensive knowledge within their chosen specialty and developing knowledge of related disciplines. You has the ability to recommend enhancements to internal policies, processes and procedures based on new requirements, legislation, etc.;
- You provides solutions to a wide variety of problems of greater complexity that require the regular use of creativity and ingenuity, while safeguarding compliance;
- You can ensures case processing and case quality are maintained at highest standards at all times;
- You have a strong interpersonal skills and multi-cultural /intercultural awareness; able to develop effective relationships through collaboration;
- You have good communication skills in English (written and spoken);
- You are ability to work independently. Work is reviewed from a relatively long-term perspective, towards predetermined long-range goals and objectives.
The company is one of the top 20 pharmaceutical companies in the world. As a young and forward-thinking company, she is dedicated to improving the lives of people around the world through the introduction of innovative and reliable pharmaceutical products.