Senior Patient Safety Manager-Shanghai

Title:

Senior Patient Safety Manager-Shanghai

Company:

Ipsen (Shanghai) Trade Co., Ltd

 

About Ipsen:

Ipsen is a mid-sized global biopharmaceutical company with a focus on transformative medicines in three therapeutic areas: Oncology, Rare Disease and Neuroscience. Supported by nearly 100 years of development experience, with global hubs in the U.S., France and the U.K, we tackle areas of high unmet medical need through research and innovation.

 Our passionate teams in more than 40 countries are focused on what matters and endeavor every day to bring medicines to patients in 88 countries. We build a workplace that champions human-centric leadership and fosters a culture of collaboration, excellence and impact. At Ipsen, every individual is empowered to be their true selves, grow and thrive alongside the company’s success. Join us on our journey towards sustainable growth, creating real impact on patients and society!

For more information, visit us at https://www.ipsen.com/ and follow our latest news on LinkedIn and Instagram.

Job Description:

China Patient Safety Manager is responsible for manage patient safety operation team (vendor and contractor), lead the team to deliver objectives. At the same time this role is in charging of safety management via collaborating with Global Patient Safety (GPS), to identify the product safety risk and take actions mitigating the risks. Acting as local QPPV backup during Patient Safety Head absence. This role should understand company’s code & compliances policy, and to manage the daily activity to align with these accordingly.

Product Safety Surveillance

• Closely monitor the post market products safety profile in China patients
• Check regulations regularly to understand regulatory requirements and updates. Ensure the implementation locally.
• Provides feedback to Global Patient Safety (GPS) organization; collaborate with global teams on product safety management from local safety perspective.
• Serve as China Safety liaison to internal/external customers. Provide valuable inputs to partners from safety perspective to support:
• Post-market study implementation locally
• Solving of litigation defense
• Work out China risk mitigation plan to specific products, and lead the cross-functional team to implement, manage the product safety risks in China market.
• Deliver safety trainings to working peers or partners in order to ensure the full safety compliance in China.

Lead and manage PV local vendor

• Set up role & responsibility to PV operation group (outsourced to local PV vendor and contractor), ensure an effective framework to fully compliant to regulations and global SOPs on AE data processing
• Set up PV capacity model and oversight the vendor to build up capability on safety data processing and supporting to product safety surveillance
• Develop work aids in line with functional SOPs to ensure PV operation group carry out daily works successfully
• Review and monitor the performance monthly of PV Operation group

Ensure full compliance to regulations

• Provide strategic input into China Authority submissions, queries, and discussions.
• Guarantee the submission of various HA submissions, including PSUR/PBRER, PV Annual report and any other HA submission. Maintain the submission and tracking according to HA and global requirements.
• Ensure the quality of safety contents in China product label

Knowledge & Experience (essential):

5 years working experience in Pharmacovigilance in pharmaceutical companies

People management experience on pharmacovigilance operational team

Knowledge & Experience (preferred):

More than 7 years for Pharmacovigilance and/or relevant positions in multi-national pharmaceutical companies

Experience in both pre-marketing and post-marketing clinical trials will be preferred.

Education / Certifications (essential):

Bachelor in Medicine/Pharmacy Experience:

Education / Certifications (preferred):

Master in Clinical Medicine

Language(essential):

• Excellent English in listening, speaking, reading and writing

• Good knowledge of national and international regulations in relevant areas

• Knowledge of pharmacovigilance processes

• Drug development process knowledge

• ICH guidelines, EMA GVP and China GVP, GCP as well as applicable local and global regulations

• Excellent English language, and presentation skills 

Thank you for considering Ipsen as an employer of choice. We wish you all the best with your application.