患者安全策略负责人

Posté 10 déc. 2021

Beijing, Beijing - China

Demander un identifiant 235911

Détails

 

A career at our company is an ongoing journey of discovery: our 58,000 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.

 


Your role:

As the Group Leader Development Safety China to 

-Bridge local and Global Patient Safety (GPS) to ensure the proper and sufficient communication and implementation of local regulatory requirements 
-Safety related support of R&D Program, provide strategic medical safety leadership for NDA/BLA submission and Product Launch in China from safety perspective, in close collaboration with China project team and GPS team (each global product Safety Strategy Lead and global PV Scientists) with the focus on local submission 
Represent GPS China on China project teams and relevant working taskforce for development compounds/products, ensuring the safety deliverables in timely manner

  • Provide Contribute to preparation of safety parts of submission dossiers to be submitted to China health authority, provide safety input in preparing ATO closely interacting with relevant global Safety Strategy Leads and global PV Scientists 
  • Contribute to the discussion for portfolio management in China from safety perspective, if applicable
  • In collaboration with the global SSL ensure implementation of effective proactive medical safety strategies for the assigned development compounds and/or Investigational medicinal products; delivery of safety aspects for clinical development; and risk management and benefit-risk evaluation
  • Deliver safety aspects to clinical trial activities as appropriate; for example, clinical study protocols /reports/Investigator’s Brochure/CSR etc. for local China and regional studies
  • Contribute to set up Clinical Trial Safety Management processes and review safety parts in documents related to outsourcing of trials, where applicable 
  • Support the implementation of local risk minimization activities such as PMS, distribution of education material, etc. 
  • Provide input into answers to inquiries from local investigators 

-Post-marketing safety monitoring (Life cycle management)
-Representation of GPS on safety aspects for the product externally as appropriate, e.g. preparation for and attendance at Chinese regulatory authority meetings, interactions with external advisers or opinion leaders, collaboration with colleagues from partnership companies for co-development or co-marketing etc
-Provide GCP onsite inspection support involving GPS 

 

Who you are:

Necessary professional experience
- Medical experience as a physician
- Broad industry experience (minimum 5 years), preferably including both clinical development and pharmacovigilance experience (including medical safety evaluation and safety decision-making based on clinical acumen and medical judgment)
- Excellent knowledge of product development process and experience of cross-functional teamwork
- Good medical understanding of the relevant therapeutic area(s)
- Professional experience in an international environment
 

HR: 95598

Functional Area: Regulatory 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

 

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