Associate Manager - Global Compliance, Quality and Metrics-1407934W
Description
POSITION
Associate Manager, Global Compliance, Quality and Metrics
(Based in Manila, Philippines)
BASIC PURPOSE OF THE POSITION
The Associate Manager, Global Consumer Pharmacovigilance Operations is responsible for the oversight of the PV Global Regulatory Compliance, Quality Review Operations, and Metricsing Operations in accordance with company standard operating procedures and work instructions and local and global regulations. In addition, the Associate PV Manager is also expected to perform oversight of the other units in the Pharmacovigilance Operations as needed.
PRINCIPAL RESPONSIBILITIES
-
Develop and maintain comprehensive and current knowledge of current regulations governing the processing and reporting of safety data, Standard Operating Procedures and Work Instructions
-
Assume back-up oversight of Global Case Receipt, Global Case Processing, and Global Regulatory Submission Operations as necessary
-
Lead problem solving and resolutions efforts to include management of risk, contingencies and issues
-
Manage and coordinate efforts of cross-functional project teams to support milestone achievement and ensure consistent operational processes and compliance with standard processes and regulations
-
Perform oversight management of Quality Review of ICSRs in the Pharmacovigilance Operations
-
Monitor case receipt and regulatory compliance; and maintain compliance reports and scorecards
-
Maintain compliance reports for inclusion in the QPPV Pharmacovigilance System Master File (PSMF)
-
Liaise with Local Safety Officers (LSO) worldwide and Regional Medical Safety Officers for review and reconciliation of regulatory and case receipt compliance reports
-
Ensure that the compliance measures and processes are aligned with organizational strategy and comply with all regulations
-
Develop and implement CAPA as appropriate to resolve compliance deviations of safety reports
-
Develop and maintain inspection readiness of safety operations metrics and support regulatory inspections when required
-
Supervise/ manage compliance operations team to ensure operational effectiveness and efficiency
-
Develop and implement a training plan on compliance-related activities for Compliance Analysts
-
Determine on-going needs of training and train Compliance Analysts
Qualifications
EDUCATION & EXPERIENCE REQUIREMENT
- Graduate of any medically related course (Pharmacy, Nursing, Medicine)
- 1 year experience in product safety, product safety processes and/or regulatory affairs, 2 years experience in Pharmaceutical company
- Ability to analyze and interpret data from safety databases and medical literature, and present complex data in a concise and understandable scientific manner both orally and in written format, is essential
- Strong leadership skills, Displays initiative, Strong communication and presentation skills
- Process Excellence skills and experience, Strong collaboration and interpersonal skills, Results oriented and able to independently create and deliver, Diligence in record keeping and records
Primary Location:Asia Pacific-Philippines-National Capital-Manila
Organization: Johnson & Johnson International (Singapore) Pte. Ltd. - ROHQ
Job Function: Drug & Product Safety Operations
Description
POSITION
Associate Manager, Global Compliance, Quality and Metrics
(Based in Manila, Philippines)
BASIC PURPOSE OF THE POSITION
The Associate Manager, Global Consumer Pharmacovigilance Operations is responsible for the oversight of the PV Global Regulatory Compliance, Quality Review Operations, and Metricsing Operations in accordance with company standard operating procedures and work instructions and local and global regulations. In addition, the Associate PV Manager is also expected to perform oversight of the other units in the Pharmacovigilance Operations as needed.
PRINCIPAL RESPONSIBILITIES
-
Develop and maintain comprehensive and current knowledge of current regulations governing the processing and reporting of safety data, Standard Operating Procedures and Work Instructions
-
Assume back-up oversight of Global Case Receipt, Global Case Processing, and Global Regulatory Submission Operations as necessary
-
Lead problem solving and resolutions efforts to include management of risk, contingencies and issues
-
Manage and coordinate efforts of cross-functional project teams to support milestone achievement and ensure consistent operational processes and compliance with standard processes and regulations
-
Perform oversight management of Quality Review of ICSRs in the Pharmacovigilance Operations
-
Monitor case receipt and regulatory compliance; and maintain compliance reports and scorecards
-
Maintain compliance reports for inclusion in the QPPV Pharmacovigilance System Master File (PSMF)
-
Liaise with Local Safety Officers (LSO) worldwide and Regional Medical Safety Officers for review and reconciliation of regulatory and case receipt compliance reports
-
Ensure that the compliance measures and processes are aligned with organizational strategy and comply with all regulations
-
Develop and implement CAPA as appropriate to resolve compliance deviations of safety reports
-
Develop and maintain inspection readiness of safety operations metrics and support regulatory inspections when required
-
Supervise/ manage compliance operations team to ensure operational effectiveness and efficiency
-
Develop and implement a training plan on compliance-related activities for Compliance Analysts
-
Determine on-going needs of training and train Compliance Analysts
Qualifications
EDUCATION & EXPERIENCE REQUIREMENT
- Graduate of any medically related course (Pharmacy, Nursing, Medicine)
- 1 year experience in product safety, product safety processes and/or regulatory affairs, 2 years experience in Pharmaceutical company
- Ability to analyze and interpret data from safety databases and medical literature, and present complex data in a concise and understandable scientific manner both orally and in written format, is essential
- Strong leadership skills, Displays initiative, Strong communication and presentation skills
- Process Excellence skills and experience, Strong collaboration and interpersonal skills, Results oriented and able to independently create and deliver, Diligence in record keeping and records
Primary Location:Asia Pacific-Philippines-National Capital-Manila
Organization: Johnson & Johnson International (Singapore) Pte. Ltd. - ROHQ
Job Function: Drug & Product Safety Operations