湖州招聘

Research Related Activities (RRA)–

· Ensure that all RRA programs are assessed for impact to AE generation and PV requirements are in place and in line with global and local SOPs.

· Ensure that any new programs or any significant changes in existing programs are tracked and updated in the Trial Master Source (TMS) and HIVE inventory.

· Ensure training on PV obligations is conducted for all J&J and service provider staff involved in RRA programs with annual refresher training.

· Monitor the service provider to ensure PV obligations are being fulfilled, including appropriate collection, follow up and reconciliation of safety information according to local procedures.

· Oversee vendor quality assessments of relevant service providers are performed.

· Ensure that proposed audits of RRA program service providers/vendors are communicated to relevant stakeholders prior to audit.

· Support local BQ to conduct vendor audits and complete vendor Corrective Action Plans (CAPAs).

Collaborate & Support

Training –

· Maintain a version-controlled training matrix/plan for local PV personnel which includes, but is not limited to, local SOPs, local regulations and references to the global affiliate PV courses allocated in ComplianceWire (CW) and SUMMIT.

· Ensure training compliance with GMO and local PV training requirements and other mandatory training as required by GMO.

· Ensure all Affiliate employees and contractors for all countries the LSO s responsible for (including Global or Regional staff based at the LOC) are aware of their responsibility to complete annual adverse event identification and reporting training. This PV training is to be undertaken at least annually, and appropriate training records shall be maintained. Ensure this training is completed.

· Ensure that any training of partner company and vendor staff is completed according to local contract requirements, and appropriately documented.

Audit & inspection readiness –

· Lead the audit / inspection preparations for internal PV audits, Johnson & Johnson Regulatory Compliance (JJRC) and Bioresearch, Quality & Compliance (BRQC) inspections.

· Act as the key affiliate contact for all PV audits.

· Lead the review of 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 affiliate level at all times

Business Continuity–

Filing & archiving –

EDUCATION & EXPERIENCE REQUIREMENTS:

· Medical, pharmacy or life-sciences degree (or equivalent)

· 2-3 years of experience in PV essential; experience working in the pharmaceutical industry is strongly preferred

· Extensive experience in conducting training

· Knowledge of PV regulations

· Experience using global safety database desirable

· Demonstrated attention to detail

· Excellent written and spoken communication and presentation skills

· Effective decision maker with the ability to assess impact of actions taken locally on the global PV system

· Fluency in written and oral English in order to facilitate communications with GMO, regional Medical, other global functions, and Health Authority

· High customer orientation

· Strong commitment to compliance with the relevant rules and procedures, and to scientific quality and integrity

· Sound judgment, strong planning and organizational skills, and the ability to get things done

· Demonstrated strong sense of urgency

Strong influencing skills with the ability to explain and defend a position which is in the best interests of patient safety