Senior Drug Safety Manager
- Shanghai, China
Site Name: China - Shanghai - PuDong New District - Lane 999 Huanke Road - Building18
Posted Date: Mar 31 2020
Are you looking for a high-profile safety role that ensures the accuracy of critical safety data across multiple geographies? If so, this Safety Pharmacovigilance Manager role could be an ideal opportunity to explore.
As a Safety Pharmacovigilance Manager, you will manage the set-up, handover, and oversight of the Pharmacovigilance (PV) Hub's various country requirements, ensuring high PV standards and following regulatory mandated requirements across designated country clusters. You will be responsible to ensure there is close alignment with respective General Managers (GMs) to ensure governance requirements.
This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:
- To be responsible for maintaining and improving the quality management system of pharmacovigilance including but not limiting to
- Regularly reviewing and updating the relevant procedure documents for Pharmacovigilance (PV) activities.
- Delivering effective AE reporting training to internal and external partners.
- Ensure PVaudit and inspection readiness
- Managing and overseeing the third party with regard to PV activities
Mainly focusing on
Safety data Exchange Agreement (SDEA):
Perform due diligence of third party PV system; Prepare, communicate and manage SDEAs; monitor compliance with SDEA in the local operating company.
Management Monitoring Activities:
Plan and conduct PV Management Monitoring activities and continuously identify PV quality/compliance risks; Follow up CAPAs until closure to mitigate the poor quality/non-compliance risks in GSK China.
Third Party Oversight:
Oversight and management of key third parties to ensure compliance with GSK requirements.
MR, PSP, IDM projects:
Management of MR, PSP, and IDM projects to ensure compliance with GSK requirements.
China PV working instructions:
Management of China PV working instructions and coordinating process authors to make sure all China PV processes are specified in written.
China PV training:
Plan and review the training schedule and materials, and conduct PV trainings to enable internal GSK staff and external stakeholders (vendors, license partners etc.) to fully understand and comply with PV reporting requirements in their roles.
To assist other colleagues to process AE cases in case of sudden rise of case volume and risks of non-compliance of regulatory reporting.
8. Other miscellaneous PV tasks:
Perform other PV tasks assigned by line manager, where necessary.
Basic Qualifications: We are looking for professionals with these required skills to achieve our goals:
- PharmD (Pharmacists degree)
- 2 or more years of experience working in the pharmaceutical industry
- Experience in Pharmacovigilance and Medical Information regulatory requirements, systems, and processes
- Experience with medical governance across multiple geographies
Preferred Qualifications: If you have the following characteristics, it would be a plus:
- Doctor of Medicine (MD)
- Strong collaboration, planning, execution, and communication skills
- Ability to influence across a highly-matrixed organization
Our values and expectationsare at the heart of everything we do and form an important part of our culture.
These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities:
- Operating at pace and agile decision-making - using evidence and applying judgement to balance pace, rigour and risk.
- Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
- Continuously looking for opportunities to learn, build skills and share learning.
- Sustaining energy and well-being
- Building strong relationships and collaboration, honest and open conversations.
- Budgeting and cost-consciousness
Our goal is to be one of the world's most innovative, best performing and trusted healthcare companies. We believe that we all bring something unique to GSK and when we combine our knowledge, experiences and styles together, the impact is incredible. Come join our adventure at GSK where you will be inspired to do your best work for our patients and consumers. A place where you can be you, feel good and keep growing.
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