[사노피 아벤티스 코리아] Post Marketing Surveillance lead 채용

JOB PURPOSE/PRIORITIES:

The Post Marketing Surveillance lead (PMSL) is assigned to fulfil country pharmacovigilance obligations relating to medicinal products and biologics for which Sanofi holds the Marketing Authorisation. The PMS Lead is primarily responsible for the conduct of post-approval PMS commitments according to country regulations.

ORGANIZATIONAL CONTEXT:

(See Organizational chart attached)

Internal stakeholders: Associate Study Lead (ASL), IPS, CPA, CROM, CPL Manager, CSU Head, system expert, Safety Lead, Medical Affairs, Regulatory Affairs

SUPERVISED RESOURCES:

Associate Study Lead (ASL), IPS, CPA

KEY ACCOUNTABILITIES:

In collaboration with Medical affairs and Contract Research Organisation (CRO), participate in the development of PMS strategy and ensure that all active Surveillance, local Phase IV and comparative observational studies comply with local regulations and are aligned with global processes and governance.

Oversee and coordinate all aspects of active Surveillance, local Phase IV and comparative observational studies utilizing the appropriate local and global functions to deliver the required data for re-examination and RMP by the Korean regulatory authority.

Act as an interface with MFDS regarding PMS in collaboration with CSH (Country Safety Head).

Establish and manage communication with local/global stakeholders for PMS operations.

Coordinate the development and maintenance (including revision and archiving as necessary) of PMS plans and related documents based on PMS strategy agreed by all relevant stakeholders.

Local support and interface of CROs and vendors, in alignment with global clinical development and operations procedures and governance directives.

Ensure appropriate contracts with the study site are in writing and preserved according to the Korean regulatory authority regulations.

Coordinate data gathering for the preparation of PMS/RMP periodic report and re-examination report.

Review, implement and maintain all PMS SOPs, as applicable, to enable PMS to be implemented accurately and smoothly and to align with company’s policies, standards and procedures.

Implement PMS training for all relevant internal stakeholders in alignment with systems and processes used globally.

Support investigator / study site communication as necessary.

Coach Jr. CPL to conduct PMS operation.

JOB-HOLDER ENTRY REQUIREMENTS:

Language skills:

Ability to present clear messages accurately in both written and spoken English from complex information/data to all

levels in the organization.

Education:

University degree in Health Sciences or equivalent

Experience & knowledge:

5+ years’ experience work in Clinical Operations. PMS work experience is preferred.

Core competencies:

Knowledge of Korean regulatory authority requirements, KGCP/ICH-GCP.

Knowledge of Korean PV and Risk Management regulatory requirements

Management, leadership and communication skills, organizational, analytical and planning abilities, reactivity to emergent needs, able to prioritize, time management.

Influencing skills in a matrix organization, through a collaborative style with the establishment of credibility and strong working relationships with cross-functional teams.

[지원방법] 홈페이지 입사지원 => https://en.jobs.sanofi.com/job/seoul/post-marketing-surveillance-lead/20873/16010796