Regional Medical Safety Officer - São Paulo - Consumer-8615140415
Descrição
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 (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 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.
Duties & Responsibilities
- Develop 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
- 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
- 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
- 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
- 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
- Escalate issues as appropriate
- For products marketed/licensed in their regions and other products assigned to them by management:
- Provide medical safety input to the in maintenance of labeling safety information
- 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
- Escalate as appropriate to direct management and other functions safety signals, potential safety issues as per appropriate Company procedures
J2W:LI LATAM
Qualificações
Education and experience
- Doctor of Medicine, (MD)
· Specialization in primary care medicine, public health, epidemiology, or related disciplines desirable
· Experience in clinical/pharmaceutical medicine and also experience in pharmacovigilance
· Demonstrated skills/knowledge of regulatory requirements for global pharmacovigilance
· Experience in risk evaluation and mitigation
Local principal: America Latina-Brasil-São Paulo-São Paulo
Organização: J&J do Brasil Indústria e Comércio de Produtos para Saúde Ltda. (7600)
Área: Assuntos Médicos
Descrição
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 (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 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.
Duties & Responsibilities
- Develop 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
- 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
- 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
- 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
- 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
- Escalate issues as appropriate
- For products marketed/licensed in their regions and other products assigned to them by management:
- Provide medical safety input to the in maintenance of labeling safety information
- 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
- Escalate as appropriate to direct management and other functions safety signals, potential safety issues as per appropriate Company procedures
J2W:LI LATAM
Qualificações
Education and experience
- Doctor of Medicine, (MD)
· Specialization in primary care medicine, public health, epidemiology, or related disciplines desirable
· Experience in clinical/pharmaceutical medicine and also experience in pharmacovigilance
· Demonstrated skills/knowledge of regulatory requirements for global pharmacovigilance
· Experience in risk evaluation and mitigation
Local principal: America Latina-Brasil-São Paulo-São Paulo
Organização: J&J do Brasil Indústria e Comércio de Produtos para Saúde Ltda. (7600)
Área: Assuntos Médicos