PV agreement and Compliance Specialist / Janssen Job

Job description

PV agreement and Compliance Specialist / Janssen-1500031220WDescriptionPrimary responsibility; Pharmacovigilance agreement (PVA) & External Service Provider Contracts
- Be a primary contact and responsible for Pharmacovigilance Agreement (PVA) & External Service Provider Contract related activities within Japan Safety & Surveillance (JSS) Division
- Draft/review and coordinate contracts between Janssen Japan and business partners for outsourcing activities for safety management information – ensures input from stakeholders
- Review (if not owned by PV) and draft (if owned by PV) contracts and PVA to ensure transfer of AE information between Janssen Japan and business partners
- ensures input from stakeholders
- Draft, review and/or coordinate contracts/agreements between companies for supply agreements
- Maintain PVA and Contracts inventory for JSS
- Ensure International Contract Database (ICD) is up to date with Janssen Japan contracts and PVASubsequent responsibility; Compliance
- Ensure that product safety management information is properly handled in relevant departments in Janssen Japan and is exchanged effectively and timely between Janssen Japan and business partners.
- Oversee the monitoring of quality and compliance of the AE reporting process and oversees the development, coordination and tracking of related metricsMonitor quality of JSS responsible regulatory submission documentsQualifications/Previous industry and/or clinical experience with a focus on pharmaceutical safety related areas, including pharmacovigilance and/or post-marketing surveillance preferred. Typically demonstrated by a minimum of 5 years pharma experience.1. In depth knowledge and experience with regulatorycompliance with focus on GVP/GPSP, and experience of international safety reporting/regulations desired.2. Demonstrate leadership skills, ability to lead a team3. Proven team leadership within a matrix environment desired.4. Excellent verbal, written and presentation skills.5. Good computer skills (Word, email) and familiarity with safety systems.
Knowledge or experience with Excel, PowerPoint, Visio preferred.
Primary Location:Asia Pacific-Japan-Tokyo-To-ChiyodaOrganization: Janssen Pharmaceutical K.K. (7195)Job Function: Pharmacovigilance