Johnson & Johnson companies are equal opportunity employers.
REGIONAL MEDICAL SAFETY OFFICER (RMSO)-7177140325
Description
Johnson & Johnson Consumer Products Company, a division of Johnson & Johnson Consumer Companies, Inc., is recruiting for a Regional Medical Safety Officer (RMSO), in Horsham, PA or Skillman, NJ.
Johnson & Johnson Consumer Products Company, a division of Johnson & Johnson Consumer Companies, Inc. develops and markets baby care, wound care and skin care products that address the needs of consumers and health care professionals and incorporate the latest innovations. The portfolio includes heritage brands Visine® and BAND-AID® Brand, as well as leading skin care brands such as Cortaid®, KY® and Listerine Brand®.
Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.
The Regional Medical Safety Officer (RMSO) reports into the Medical Safety Organization and works in collaboration with the MSO(s) who has global responsibilities for a therapy area to develop the strategy and oversee the execution of the risk management and pharmacovigilance activities for all products licensed/marketed in a region. The RMSO owns the post-marketing safety surveillance and risk management recommendations for allocated products of local responsibility product of local opportunity (POLO) including provision of medical safety input into their labelling, collaborates with matrix teams from other J&J functions and licensing partners on assessment of safety issues, co-chairs SMTs for these products. The RMSO in alignment with relevant MSOs provides medical safety expert input into product development of regional products, aggregate safety data assessments including Health Hazard Evaluations of all products licensed/marketed in the region and any other products assigned by management. The RMSO, leads development of medical safety assessments of quality issues with potential impact on their safe use, and together and presents agreed with the MSO and SMT medical safety position at pre-QRBs and Quality Review Boards (QRBs). The RMSO ensures communication of potential and known risks, when appropriate, to direct management, and personnel in all other relevant functional areas as per appropriate Company procedures.
The Regional Medical Safety Officer (RMSO) develops surveillance programs for the allocated POLOs and oversee the conduct of all investigations of medical safety signals and issues through the product life cycle and in cooperation with other functional groups within the Medical Safety Organization and J&J as required/ S/he will oversee the development of medical safety content of local risk management plans and risk mitigation strategies and approve final version of medical safety content of plans/strategies for allocated POLOs, provide input to the core management plans and oversee implementation of risk mitigation strategies on their territories. S/he will provide input into product development process and contribute to the design and interpretation of Clinical Investigations and non-Clinical Safety Studies for POLOs and regional products. This individual will lead in collaboration with MSO,SMT and Quality Assurance and Compliance management of GMP events with potential impact on safety, prepare Health Hazard Evaluations / Medical Safety Assessments for all products licensed/marketed in the region and other products assigned by management, represent Medical Safety position at pre-QRB and QRB meetings for all products within the scope their responsibility, provide medical safety input to the local/regional Management Review Boards, including information on observed trends of AEs for products of their responsibility and ensure performing of relevant trending as needed, and provide medical safety expertise to Quality and Compliance Organization with out of trend assessments and root cause analysis of non-conformances where appropriate.
For the POLOs under his/ her purview, co-chair the Safety Management Teams (SMT) together with the MSO responsible for the therapeutic area, which are product-based, cross-functional teams responsible for review, assessment, and evaluation of Medical Safety data arising from any source throughout the a product’s lifecycle. Responsibilities in this capacity include: review available medical safety information from multiple sources and making timely decisions including risk mitigation recommendations and input into product risk management plans; ensure that SMT are in place for all products under their purview; ensure that SMT makes timely decisions on the medical safety of products in accordance with established policies and procedures and oversee their implementation; and escalate issues as appropriate.
For products marketed/licensed in their regions and other products assigned to them by management, : the Regional Medical Safety Officer (RMSO) will provide medical safety input to the in maintenance of labeling safety information. S/he will represent the medical safety in CCDS Labeling Working Group , provide medical safety input to the questions from regulatory authorities, advise on the appropriate medical safety strategy for regulatory authority submissions of safety data and provide input into development of safety elements of the submissions as required by the regional regulatory, participate in SMT meetings chaired by the MSO responsible for the therapeutic area, and escalate as appropriate to direct management and other functions safety signals, potential safety issues as per appropriate company procedures.
Qualifications
A Doctor of Medicine (MD) or a Doctor of Osteopathic Medicine (DO) is required. Specialization in primary care medicine, public health, epidemiology, or related disciplines is desirable. A minimum of 8 years’ experience in clinical/pharmaceutical medicine is required. 2 years of experience in pharmacovigilance is desirable. Demonstrated skills/knowledge of regulatory requirements for global pharmacovigilance is required. Experience in risk evaluation and mitigation is required. This position is located in Horsham, PA or Skillman, NJ. There will be less than 25% travel.
BE VITAL in your career; be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.
J2W: LI NA
J2W:BIO
J2W:NSJ
J2W:MZ
Primary Location:North America-United States-Pennsylvania-Horsham
Other Locations:North America-United States-New Jersey-Skillman
Organization: Johnson & Johnson Consumer Inc. (6071)
Job Function: Drug & Product Safety Science
Certain sites within the Johnson & Johnson Family of Companies participate in E-Verify as appropriate in accordance with Company guidelines and federal or state law. To learn more about the government sponsored program and to see a list of the sites that are currently enrolled, please click here.
Johnson and Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, protected veteran status, or disability status, or any other characteristic protected by law.
EEO is the Law
EEO is the Law GINA Supplement
REGIONAL MEDICAL SAFETY OFFICER (RMSO)-7177140325
Description
Johnson & Johnson Consumer Products Company, a division of Johnson & Johnson Consumer Companies, Inc., is recruiting for a Regional Medical Safety Officer (RMSO), in Horsham, PA or Skillman, NJ.
Johnson & Johnson Consumer Products Company, a division of Johnson & Johnson Consumer Companies, Inc. develops and markets baby care, wound care and skin care products that address the needs of consumers and health care professionals and incorporate the latest innovations. The portfolio includes heritage brands Visine® and BAND-AID® Brand, as well as leading skin care brands such as Cortaid®, KY® and Listerine Brand®.
Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.
The Regional Medical Safety Officer (RMSO) reports into the Medical Safety Organization and works in collaboration with the MSO(s) who has global responsibilities for a therapy area to develop the strategy and oversee the execution of the risk management and pharmacovigilance activities for all products licensed/marketed in a region. The RMSO owns the post-marketing safety surveillance and risk management recommendations for allocated products of local responsibility product of local opportunity (POLO) including provision of medical safety input into their labelling, collaborates with matrix teams from other J&J functions and licensing partners on assessment of safety issues, co-chairs SMTs for these products. The RMSO in alignment with relevant MSOs provides medical safety expert input into product development of regional products, aggregate safety data assessments including Health Hazard Evaluations of all products licensed/marketed in the region and any other products assigned by management. The RMSO, leads development of medical safety assessments of quality issues with potential impact on their safe use, and together and presents agreed with the MSO and SMT medical safety position at pre-QRBs and Quality Review Boards (QRBs). The RMSO ensures communication of potential and known risks, when appropriate, to direct management, and personnel in all other relevant functional areas as per appropriate Company procedures.
The Regional Medical Safety Officer (RMSO) develops surveillance programs for the allocated POLOs and oversee the conduct of all investigations of medical safety signals and issues through the product life cycle and in cooperation with other functional groups within the Medical Safety Organization and J&J as required/ S/he will oversee the development of medical safety content of local risk management plans and risk mitigation strategies and approve final version of medical safety content of plans/strategies for allocated POLOs, provide input to the core management plans and oversee implementation of risk mitigation strategies on their territories. S/he will provide input into product development process and contribute to the design and interpretation of Clinical Investigations and non-Clinical Safety Studies for POLOs and regional products. This individual will lead in collaboration with MSO,SMT and Quality Assurance and Compliance management of GMP events with potential impact on safety, prepare Health Hazard Evaluations / Medical Safety Assessments for all products licensed/marketed in the region and other products assigned by management, represent Medical Safety position at pre-QRB and QRB meetings for all products within the scope their responsibility, provide medical safety input to the local/regional Management Review Boards, including information on observed trends of AEs for products of their responsibility and ensure performing of relevant trending as needed, and provide medical safety expertise to Quality and Compliance Organization with out of trend assessments and root cause analysis of non-conformances where appropriate.
For the POLOs under his/ her purview, co-chair the Safety Management Teams (SMT) together with the MSO responsible for the therapeutic area, which are product-based, cross-functional teams responsible for review, assessment, and evaluation of Medical Safety data arising from any source throughout the a product’s lifecycle. Responsibilities in this capacity include: review available medical safety information from multiple sources and making timely decisions including risk mitigation recommendations and input into product risk management plans; ensure that SMT are in place for all products under their purview; ensure that SMT makes timely decisions on the medical safety of products in accordance with established policies and procedures and oversee their implementation; and escalate issues as appropriate.
For products marketed/licensed in their regions and other products assigned to them by management, : the Regional Medical Safety Officer (RMSO) will provide medical safety input to the in maintenance of labeling safety information. S/he will represent the medical safety in CCDS Labeling Working Group , provide medical safety input to the questions from regulatory authorities, advise on the appropriate medical safety strategy for regulatory authority submissions of safety data and provide input into development of safety elements of the submissions as required by the regional regulatory, participate in SMT meetings chaired by the MSO responsible for the therapeutic area, and escalate as appropriate to direct management and other functions safety signals, potential safety issues as per appropriate company procedures.
Qualifications
A Doctor of Medicine (MD) or a Doctor of Osteopathic Medicine (DO) is required. Specialization in primary care medicine, public health, epidemiology, or related disciplines is desirable. A minimum of 8 years’ experience in clinical/pharmaceutical medicine is required. 2 years of experience in pharmacovigilance is desirable. Demonstrated skills/knowledge of regulatory requirements for global pharmacovigilance is required. Experience in risk evaluation and mitigation is required. This position is located in Horsham, PA or Skillman, NJ. There will be less than 25% travel.
BE VITAL in your career; be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.
J2W: LI NA
J2W:BIO
J2W:NSJ
J2W:MZ
Primary Location:North America-United States-Pennsylvania-Horsham
Other Locations:North America-United States-New Jersey-Skillman
Organization: Johnson & Johnson Consumer Inc. (6071)
Job Function: Drug & Product Safety Science
Certain sites within the Johnson & Johnson Family of Companies participate in E-Verify as appropriate in accordance with Company guidelines and federal or state law. To learn more about the government sponsored program and to see a list of the sites that are currently enrolled, please click here.
Johnson and Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, protected veteran status, or disability status, or any other characteristic protected by law.
EEO is the Law
EEO is the Law GINA Supplement