Local Safety Officer-000009HR
Description
Build Your Career with Janssen-Cilag
Janssen-Cilag is one of the world's most comprehensive and broadly based healthcare companies under Johnson & Johnson. We engage in the discovery, manufacturing and marketing of innovative products to improve people's health and quality of life. At Janssen, you'll be working with one of the world's leading research-based pharmaceutical companies. You will personally contribute to improving the health and quality of life of patients and their nearest and dearest through innovative products, information and services.
Why work here?
You'll thrive in our exciting and dynamic corporate culture, constantly seeking new challenges, making your own independent contributions to the company's success. In the cooperative and open climate that prevails at Janssen, you have the best chance for an attractive and long-term professional future. We are now providing job opportunities and career development for qualified candidates in the following position:
Local Safety Officer
Business Sector: Pharmaceutical
Job Responsibilities
Reporting to the Medical Affairs Director, the LSO is responsible for ensuring Pharmacovigilance inspection readiness at the Operating company level at all times.
- Maintain overall responsibility for the coordination of safety reporting requirements, as required for Marketing Authorization holders (MAH). Manage and maintain active involvement in day-to-day AE reporting. Key responsibilities include collection, review and reporting of adverse events (AEs), Adverse Events combined with product quality complaints (AE+PQCs) and pregnancy reports, obtained through the following sources: spontaneous, solicited, clinical trials, related activities, local Competent Authorities and all other potential sources. Detect and report AEs from Local Scientific Literature. Track AE cases and perform case follow-ups as needed. Undertake site visits for follow-up of local cases of special interest, as appropriate. Conduct initial quality review and assessment of local individual cases. Perform regular reconciliation activities as required by company procedures and local regulations. Ensure an effective system in place for 24-hour coverage.
- Ensure implementation and compliance with global, regional and local procedural documents applicable to Pharmacovigilance. Accountable internally for ensuring that the Local Operating Company meets procedure defined timelines for management of safety information and any local regulatory agency defined timeline for submission of individual reports.
- Accountable for local operating company compliance monitoring for submissions to Competent Authorities (HAs). Reconcile compliance data provided and take appropriate corrective actions as defined by company policies and procedures.
- Collaborate with local Regulatory group for review of Aggregate Safety Reports as appropriate and ensure timely submission according to local regulations.
- Safety oversight of clinical projects conducted in the territory. Collaboration with Medical Affairs for the review and approval of safety aspects of local study protocols to ensure appropriate safety reporting to Competent Authorities, as required.
- Ensure awareness of changes in regulations which may have an impact on PV activities and responsibilities. Inform the appropriate global and regional groups ( i.e. QPPV office and regional heads) of any changes to local laws and regulations regarding Pharmacovigilance.
- Provide support for Third Party Agreements with PV implications. Ensure the PV agreement is implemented locally, as appropriate (this includes in/out license products).
- Collaborate with Regulatory Affairs to forward any safety-related inquiry or relevant communication from the Local Competent Authority to the appropriate global and regional groups (i.e. QPPV office and regional heads) as appropriate. Collaborate with appropriate departments to identify the resources and expertise needed to address/respond the question. This may include local, regional and/or global expertise.
- Where applicable, support the Qualified Person (QP) for PV to provide safety-related regulatory communication (e.g., response to request for information from Local CA), including the provision of information about the volume of sales or prescription, as appropriate.
- Ensure proper training on drug safety reporting responsibilities of Local Operating Company personnel and maintenance of awareness of drug safety reporting in general.
- Take appropriate measures to ensure that relevant safety information is available to Health Care Professionals in timely manner, if applicable. This activity may be delegated to the local Regulatory Affairs department or another appropriate department as required, as appropriate.
- In collaboration with the Medical Affairs department provide reports to the Health Authority on Post Authorization Safety Studies (PASS), as appropriate.
- Take the appropriate actions for the implementation of urgent safety restrictions, if required.
- Participate in Issue Management teams as required.
Qualifications
- Bachelor's or Master's degree of Pharmaceutical science or Medical Science
- Minimum of 2 -5 years experience in hospital pharmacy or drug safety unit in Pharmaceutical industry
- Audit experience in drug safety is preferred
- Good command of Thai and English in speaking, reading, and writing
- Knowledge in Drug Safety /Clinical Pharmacy
- Well documentation & record management
How to Apply
If you possess what we are looking for, please logon to our careers website: www.careers.jnj.com Search by country 'Thailand' or by requisition number 000009HR and apply by January 31, 2013. All applications must come through the portal.
Primary Location:Asia Pacific-Thailand-Bangkok-Bangkok
Organization: Janssen-Cilag Ltd (7335)
Relocation: Eligible
No
Job Function: Drug & Product Safety Operations
Description
Build Your Career with Janssen-Cilag
Janssen-Cilag is one of the world's most comprehensive and broadly based healthcare companies under Johnson & Johnson. We engage in the discovery, manufacturing and marketing of innovative products to improve people's health and quality of life. At Janssen, you'll be working with one of the world's leading research-based pharmaceutical companies. You will personally contribute to improving the health and quality of life of patients and their nearest and dearest through innovative products, information and services.
Why work here?
You'll thrive in our exciting and dynamic corporate culture, constantly seeking new challenges, making your own independent contributions to the company's success. In the cooperative and open climate that prevails at Janssen, you have the best chance for an attractive and long-term professional future. We are now providing job opportunities and career development for qualified candidates in the following position:
Local Safety Officer
Business Sector: Pharmaceutical
Job Responsibilities
Reporting to the Medical Affairs Director, the LSO is responsible for ensuring Pharmacovigilance inspection readiness at the Operating company level at all times.
- Maintain overall responsibility for the coordination of safety reporting requirements, as required for Marketing Authorization holders (MAH). Manage and maintain active involvement in day-to-day AE reporting. Key responsibilities include collection, review and reporting of adverse events (AEs), Adverse Events combined with product quality complaints (AE+PQCs) and pregnancy reports, obtained through the following sources: spontaneous, solicited, clinical trials, related activities, local Competent Authorities and all other potential sources. Detect and report AEs from Local Scientific Literature. Track AE cases and perform case follow-ups as needed. Undertake site visits for follow-up of local cases of special interest, as appropriate. Conduct initial quality review and assessment of local individual cases. Perform regular reconciliation activities as required by company procedures and local regulations. Ensure an effective system in place for 24-hour coverage.
- Ensure implementation and compliance with global, regional and local procedural documents applicable to Pharmacovigilance. Accountable internally for ensuring that the Local Operating Company meets procedure defined timelines for management of safety information and any local regulatory agency defined timeline for submission of individual reports.
- Accountable for local operating company compliance monitoring for submissions to Competent Authorities (HAs). Reconcile compliance data provided and take appropriate corrective actions as defined by company policies and procedures.
- Collaborate with local Regulatory group for review of Aggregate Safety Reports as appropriate and ensure timely submission according to local regulations.
- Safety oversight of clinical projects conducted in the territory. Collaboration with Medical Affairs for the review and approval of safety aspects of local study protocols to ensure appropriate safety reporting to Competent Authorities, as required.
- Ensure awareness of changes in regulations which may have an impact on PV activities and responsibilities. Inform the appropriate global and regional groups ( i.e. QPPV office and regional heads) of any changes to local laws and regulations regarding Pharmacovigilance.
- Provide support for Third Party Agreements with PV implications. Ensure the PV agreement is implemented locally, as appropriate (this includes in/out license products).
- Collaborate with Regulatory Affairs to forward any safety-related inquiry or relevant communication from the Local Competent Authority to the appropriate global and regional groups (i.e. QPPV office and regional heads) as appropriate. Collaborate with appropriate departments to identify the resources and expertise needed to address/respond the question. This may include local, regional and/or global expertise.
- Where applicable, support the Qualified Person (QP) for PV to provide safety-related regulatory communication (e.g., response to request for information from Local CA), including the provision of information about the volume of sales or prescription, as appropriate.
- Ensure proper training on drug safety reporting responsibilities of Local Operating Company personnel and maintenance of awareness of drug safety reporting in general.
- Take appropriate measures to ensure that relevant safety information is available to Health Care Professionals in timely manner, if applicable. This activity may be delegated to the local Regulatory Affairs department or another appropriate department as required, as appropriate.
- In collaboration with the Medical Affairs department provide reports to the Health Authority on Post Authorization Safety Studies (PASS), as appropriate.
- Take the appropriate actions for the implementation of urgent safety restrictions, if required.
- Participate in Issue Management teams as required.
Qualifications
- Bachelor's or Master's degree of Pharmaceutical science or Medical Science
- Minimum of 2 -5 years experience in hospital pharmacy or drug safety unit in Pharmaceutical industry
- Audit experience in drug safety is preferred
- Good command of Thai and English in speaking, reading, and writing
- Knowledge in Drug Safety /Clinical Pharmacy
- Well documentation & record management
How to Apply
If you possess what we are looking for, please logon to our careers website: www.careers.jnj.com Search by country 'Thailand' or by requisition number 000009HR and apply by January 31, 2013. All applications must come through the portal.
Primary Location:Asia Pacific-Thailand-Bangkok-Bangkok
Organization: Janssen-Cilag Ltd (7335)
Relocation: Eligible
No
Job Function: Drug & Product Safety Operations