DSLD-0, LPSA and QPPV

Posté 01 août 2022

Riyadh, Riyadh - Saudi Arabia

Demander un identifiant 252287

Détails

 

A career at our company is an ongoing journey of discovery: our 60,300 people are shaping how the world lives, works and plays through next generation advancements in Healthcare, Life Science and Electronics. 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.

 

United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.

 


Local QPPV / Patient Safety Center (PSC) Associate – Saudi Arabia  

Your role: We are seeking a Local QPPV - Patient Safety Center Associate to Our affiliate in Saudi Arabia. You will be directly accountable for and performing all Pharmacovigilance (PV) related tasks in Saudi Arabia and will be nominated as the Local QPPV to the Saudi FDA. You will establish and maintain the local PV System in accordance with global/local legislation and company standards. You are responsible to complete the documentation and maintenance of the local PV System in a validated repository in accordance with our Global Patient Safety (GPS) standards. You supervise performance and compliance of the local PV system and maintain key performing indicators within expected standards for all PV activity timelines and ensure that all documentation is carried out in a timely and compliant manner. You will provide input to the design and development of Patient Support Programs and other Patient Data Collection Systems such as Market Research Programs, Digital Media Programs etc. Monitor local PV regulations in Saudi Arabia, inform GPS on any changes with an impact on distribution rules or other PV activities, and act accordingly on the changes. You will evaluate local updates of PV regulations in collaboration with the GPS PV Intelligence Team and complete impact assessment activities in accordance with local/regional legislation and company standards and act as first point of contact to local PV related audits or Health Authority inspections as required, supporting CAPA proposals, implementation and CAPA efficiency evaluation. Your role will also include handling of PV acitivities in other Middle East countries and you will also collaborate cross-functionally both at local level as well as on global level.

Are you ready for this challenge?

Who you are:

    • You have minimum a Bachelor degree in Pharmacy  
    • You have experience in Pharmacovigilance related areas (i.e. Clinical Research, Medical or Regulatory Affairs) in the pharma industry/health authority
    • You possess a strong team-working skill - working across cultural and functional boundaries and participating in "virtual teams"
    • You have proven communication skills and process management experience
    • You are proficient in written and spoken local language and English

What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences.
We celebrate all dimensions of diversity. We believe that it drives excellence, innovation, and human progress. We care about our customers, patients, and our rich mix of people. This diversity strengthens our ability to lead in science and technology.
We are committed to creating access and opportunities for all and empower you to fulfil your ambitions. Our diverse businesses offer various career moves to seek new horizons.
Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to bring their curiosity to life!

Curious? Chat with one of our curious minds on our interactive Q&A platform and catch a glimpse of our people, values, and culture. You can also apply and find more information at https://jobs.vibrantm.com

If you would like to know more about what diversity, equity, and inclusion means to us, please visit https://www.merckgroup.com/en/company/press-positions.html

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