• Oversight on Key MS activities；

Assist with MS team from a compliance and monitoring perspective on SUSAR assessment – looking for potential local identified signals, risk control plan development (environmental impact on patient safety – site suitability and selection).
Assist with MS team on local signal detection – ensure LOC complies with any local HA signal-detection requirements, collaborate with regional and global colleagues to signal detection activities and communications.
Assist with MS team on intensive monitoring programs including Compassionate Use Program, Patient Access Program, Registries, Post-Marketing Studies – involvement with key stakeholders to ensure the programs meet local, regional or global requirements from a compliance and strategic safety perspective.
Monitor any MS service providers to ensure PV and MS obligations are being fulfilled.
Assist with MS team to contribute towards the development of an appropriate system of Risk Management in order to assure appropriate oversight for products within its responsibility
Assist MS team with the development of a China specific RMP as required according to local requirements, if applicable
Work with MS team in the collaboration with Medical Affairs and Regulatory Affairs team to ensure that RMP activities are completed on a timely manner
Ensure implementation of RMP activities are in place including documentation of completed activities
Assist with MS team on RMP status/ updates, such as identified/potential risks, missing information, educational materials, RMP based studies (status)
Assist with MS team in the review all risk management plans and other related aggregated reports to obtain information on the risk/benefit profile of products

• Product Portfolio Responsibilities；

Contribute to the oversight of the assigned cross sector product portfolio, and link with China MS team and key stakeholders
Contribute to ensuring compliance with all MS regulatory reporting requirements in a timely manner e.g. RMPs, aggregate reports.
Support the business and China MS team perform local activity review for local organized data collection programs, post marketing programs, RWE studies etc.
Escalate compliance issues in a timely manner to Line Manager and China Cross Sector Safety Lead to ensure appropriate mitigation is implemented.
Support process improvements to optimize MS activities.
Work collaboratively with local MS colleagues to ensure consistency of approach across groups.
Build and maintain effective business relationships across the LOC.
Support the MS team to provide high quality and consistent oversight and input to development of local safety initiatives and programs.
Contribute towards an environment of continuous improvement within the MS team.

• Collaborate & Support；

Collaborate with Regulatory Affairs to forward any safety-related inquiry or relevant communication from the local RA to the appropriate global and regional groups as appropriate. Collaborate with appropriate departments to identify the resources and expertise needed to address the inquiry. This may include local, regional and/or global expertise.
Support MS team in collaborations with compound teams/cross-functional teams in MS relevant areas of product lifecycle management including pre-launch activities, dossier preparation, risk minimization activity (planning, implementation, evaluation strategy), intensive monitoring programs.
Support MS team in collaborations with Medical Affairs for the review and approval of safety aspects of local study protocols to ensure appropriate safety reporting to GMS or appropriate case management center and Health Authority, as required.
Participate in projects led by the regional and global MS team and coordinate with MS team to provide MS related inputs.
Support set up of local Vendor Agreements as necessary, seek support from central functions like PV Service and Technical Contracts Group and HUB as necessary
Provide quarterly listings for the Pharma PSMF Annex B (vendor agreements) for agreements signed by local Opco and ensure accuracy and timelines
Support functional or regional specific IPV communication and giving operational trainings

• Compliance, processes & procedures；

Regular review local channels for PV regulations and notify global teams via central PV policy tracker if new regulations or changes to come- including cosmetics and medical device safety reporting requirements
Ensure compliance with the CAPA process for the reporting and investigation of exceptions (nonconformance, potential nonconformance and planned deviations).
Provide compliance metrics and information to MS manager for reporting to QPPV Office, GMS, International PV, Compliance, Strategy and Analytics (CSA), and BQ within the required timelines if required e.g. ARMA implementation, DHCP distribution
Local Compliance oversight and provide insights into metrics, lead actions as needed
Maintain awareness of local post-marketing and clinical PV legislation and guidelines relating to Medical Safety.
Assist with drafting, review, and submission of MS related reports.
Assist with the review and updating of all local MS quality documents as applicable at minimum every 3 years.
Ensure all required documents related to MS departmental activities are retained according to SOPs and regulatory requirements.
Review any changes to global quality documents and perform and track impact assessment on local quality documents; implement change management in a timely manner according to global requirements.

• Audit & inspection readiness；

Participate in audit / inspection preparations for internal PV audits, Johnson & Johnson Regulatory Compliance (JJRC) and Bioresearch, Quality & Compliance (BRQC) inspections.
Act as a contact for MS related work for all PV audits/ inspections, coordinate with MS team for preparation and requests during audits/ inspections.
Lead the review of MS-related documents prior to and during PV audits and inspections.
Ensure that any Health Authority communications are forwarded to the required PV personnel and that any responses/corrective actions are tracked and completed according to schedule.
Ensure PV inspection readiness at the LOC level at all times (for MS-related responsibilities).

• Training.

Ensure training compliance with GMO and local PV training requirements and other mandatory training as required by GMO.
Provide training within the LOC or regionally as required e.g. MS-related training to MAF/MSL
Ensure that any training of partner company and vendor staff is completed according to local contract requirements, and appropriately documented

资历
Qualifications
Experience, Skills and Knowledge:

• Medical, pharmacy or life-sciences degree (or equivalent);
• 3-5 years of experience in PV/Medical Safety is essential; experience working in the pharmaceutical industry is strongly preferred;
• Fluency in written and oral English and Mandarin;
• Knowledge in Medical/Health Sciences required;
• Knowledge of local/global legal requirements;
• Knowledge about local business models and local legal requirements;
• Knowledge of global and local Standard Operating Procedures (SOPs), and GMS database systems;

-Demonstrable insight to the implementation PV regulatory requirements for medicines, devices and cosmetics with knowledge of Global aspects of drug safety, including International AE reporting requirements and relevant country- specific variations Familiarity of general industry principles of drug development;

• Awareness of aspects of the business and strategic company goals.

主要地点
中国-陕西-
组织
西安杨森制药有限公司
工作
Drug & Product Safety Operations
Requisition ID
1905754353W