Local Safety Officer-00000CIR
Description
Company
The Johnson & Johnson Family of Companies is comprised of more than 250 operating companies in 60 countries. Our companies develop and market products in three business segments: Consumer, Medical Devices & Diagnostics and Pharmaceuticals. At least a billion people around the world are touched each day by what we do.
Johnson & Johnson has consistently received awards from prestigious organizations. Most recent recognitions include 2nd Rank in Barron's list of World's Most Respected Companies in 2010 and 4th Rank in Fortune's list of World's Most Admired Companies in 2010.
Janssen Pharmaceutica is a division of Johnson & Johnson and is actively engaged in addressing the most critical needs of patients around the worlds through 5 major therapeutic areas: Oncology, Central Nervous System, Pain, Infectious Diseases and Biological & Immunology. Janssen has been in the Philippines since 1982 and has launched different products that have led in the therapeutic areas they participate in. It can be extremely satisfying to work with physicians in delivering these healthcare solutions, both in developed and emerging markets where they can bring a powerful measure of hope to people who suffer from the ravages of their conditions.
Position
Local Safety Officer, Medical Department - Janssen Pharmaceutica
(Based in Manila, Philippines)
Principal Responsibilities
-
Set-up and maintain a pharmacovigilance system that ensures information about all suspected adverse reactions are collected, evaluated and collated.
- Write local pharmacovigilance SOPs which are consistent with global SOPs and local regulatory guidelines.
- Ensure that all adverse events received as well as periodic safety update data are reported to Benefit Risk Management and, if needed, to the Bureau of Food and Drugs according to relevant timelines.
- Carry-out an initial medical review and assessment of reported adverse events.
- Maintain a file (both digital and hard copy) of local drug safety data that could be quickly and efficiently accessed as needed.
- Conduct adverse event reporting training among all employees of J&J.
- Represent the company as a single point of contact to represent the company in safety-related issues before the regulatory agency, the media and other relevant public audiences.
- Provide technical and strategic safety input into the management team.
Key Result Areas
Pharmacovigilance System
- Proportion of identified needed SOPs which are actually written.
- Presence of an updated adverse event report database and hard-copy filing system that could be efficiently accessed as needed.
Adverse Event Reporting
- Proportion of adverse event reports received that were transmitted to BRM and BFAD.
- Proportion of adverse event reports received that were transmitted to BRM and BFAD on time.
- Proportion of adverse event reports received on which preliminary medical review and assessment was carried out.
Training
- Proportion of identified needed pharmacovigilance trainings which were actually conducted.
Company Representation
- Number of occasions when the company needed drug safety representation of relevant audiences which were properly attended.
Management Support
- Number of Occasions when technical and strategic management team input was needed which were properly attended.
Qualifications
- Bachelor Degree in Life or Health Sciences, Masters Degree in a related field or Medical Degree preferred
- Computer literate especially in database programs, experience in setting up databases preferred
- Effective oral and written communication skills, experience in writing standard operating procedures preferred
- Exceptional leadership ability and people skills, especially in getting the entire organization to comply with regulations and guidelines
- Previous experience as local safety officer or similar role preferred
- Willing to work during holidays and weekends
- GCP trained
Primary Location:Asia Pacific-Philippines-National Capital-Manila
Organization: Johnson & Johnson (Philippines) Inc. (8385)
Job Function: Drug & Product Safety Operations
Description
Company
The Johnson & Johnson Family of Companies is comprised of more than 250 operating companies in 60 countries. Our companies develop and market products in three business segments: Consumer, Medical Devices & Diagnostics and Pharmaceuticals. At least a billion people around the world are touched each day by what we do.
Johnson & Johnson has consistently received awards from prestigious organizations. Most recent recognitions include 2nd Rank in Barron's list of World's Most Respected Companies in 2010 and 4th Rank in Fortune's list of World's Most Admired Companies in 2010.
Janssen Pharmaceutica is a division of Johnson & Johnson and is actively engaged in addressing the most critical needs of patients around the worlds through 5 major therapeutic areas: Oncology, Central Nervous System, Pain, Infectious Diseases and Biological & Immunology. Janssen has been in the Philippines since 1982 and has launched different products that have led in the therapeutic areas they participate in. It can be extremely satisfying to work with physicians in delivering these healthcare solutions, both in developed and emerging markets where they can bring a powerful measure of hope to people who suffer from the ravages of their conditions.
Position
Local Safety Officer, Medical Department - Janssen Pharmaceutica
(Based in Manila, Philippines)
Principal Responsibilities
-
Set-up and maintain a pharmacovigilance system that ensures information about all suspected adverse reactions are collected, evaluated and collated.
- Write local pharmacovigilance SOPs which are consistent with global SOPs and local regulatory guidelines.
- Ensure that all adverse events received as well as periodic safety update data are reported to Benefit Risk Management and, if needed, to the Bureau of Food and Drugs according to relevant timelines.
- Carry-out an initial medical review and assessment of reported adverse events.
- Maintain a file (both digital and hard copy) of local drug safety data that could be quickly and efficiently accessed as needed.
- Conduct adverse event reporting training among all employees of J&J.
- Represent the company as a single point of contact to represent the company in safety-related issues before the regulatory agency, the media and other relevant public audiences.
- Provide technical and strategic safety input into the management team.
Key Result Areas
Pharmacovigilance System
- Proportion of identified needed SOPs which are actually written.
- Presence of an updated adverse event report database and hard-copy filing system that could be efficiently accessed as needed.
Adverse Event Reporting
- Proportion of adverse event reports received that were transmitted to BRM and BFAD.
- Proportion of adverse event reports received that were transmitted to BRM and BFAD on time.
- Proportion of adverse event reports received on which preliminary medical review and assessment was carried out.
Training
- Proportion of identified needed pharmacovigilance trainings which were actually conducted.
Company Representation
- Number of occasions when the company needed drug safety representation of relevant audiences which were properly attended.
Management Support
- Number of Occasions when technical and strategic management team input was needed which were properly attended.
Qualifications
- Bachelor Degree in Life or Health Sciences, Masters Degree in a related field or Medical Degree preferred
- Computer literate especially in database programs, experience in setting up databases preferred
- Effective oral and written communication skills, experience in writing standard operating procedures preferred
- Exceptional leadership ability and people skills, especially in getting the entire organization to comply with regulations and guidelines
- Previous experience as local safety officer or similar role preferred
- Willing to work during holidays and weekends
- GCP trained
Primary Location:Asia Pacific-Philippines-National Capital-Manila
Organization: Johnson & Johnson (Philippines) Inc. (8385)
Job Function: Drug & Product Safety Operations