Johnson & Johnson companies are equal opportunity employers.
Associate Director, Product Vigilance Operations, Consumer Medicinal Products-0962131104
Description
Johnson & Johnson Consumer Products Company, a division of Johnson & Johnson Consumer Companies, Inc., is recruiting for an Associate Director, Product Vigilance Operations, Consumer Medicinal Products, in Horsham, PA. This position can be remote anywhere in the U.S.
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 Associate Director, Product Vigilance Operations (AD, PVO) for Consumer Medicinal (CM) products is the senior pharmacovigilance operations expert and supervisor of other Product Vigilance Operations (PVO) staff in the case management and regulatory reporting of adverse event reports for the medicinal products of the Johnson & Johnson Family of Consumer Companies that are managed in the SCEPTRE safety system.
The AD, PVO-CM is accountable for the adverse event case management and regulatory reporting activities of Consumer Medicinal products. The primary accountability of the AD, PVO-CM is to establish and oversee end-to-end adverse event case management and reporting processes and ensure compliance with regulatory reporting requirements worldwide and departmental Standard Operating Procedures (SOP). As needed, the AD, PVO-CM leads cross-functional governance teams to ensure strategic alignment of priorities among key business stakeholders; manages vendor activities to ensure deliverables are met as defined in the supplier agreement; monitors key performance indicators to identify and implement process efficiencies and quality improvements; and, coordinates staff training and controlled document development to ensure consistent, standardized processes are in place. The AD, PVO-CM provides subject matter expertise and technical guidance on safety database functional requirements and enhancements to meet emerging global regulatory requirements and implementation of a global adverse event case management solution; monitors compliance metrics; and, implements corrective and preventative actions to remediate non-conformance issues.
This position will directly or indirectly oversee all pharmacovigilance operations staff involved in case processing and reporting for consumer medicinal products. Close working relationships (involving several time zones) with the Associate Director Pharmacovigilance Physicians for Consumer Medicinal Products, with management and staff of the OCMS Center for Global Safety in Manila, and safety service providers in Asia Pacific; as well as with the Qualified Person for Pharmacovigilance (QPPV) Consumer, and Safety Compliance leadership are critical. Interactions with medical and regulatory staff of Operating Companies and with colleagues responsible for Safety Informatics, Surveillance, Aggregate Reporting, and Decision Analytics, as well as the Consumer Care Center, Regulatory Affairs and Quality Assurance are expected to occur regularly.
Qualifications
A minimum of seven (7)+ years of direct or related experience in marketed product safety for medicinal products, medical devices and/or cosmetics is required with a Bachelors Degree in a human health, regulatory compliance or management of operations related field, with sound knowledge of product vigilance operations experience OR five (5) + years of direct or related experience in marketed product safety for medicinal products, medical devices and/or cosmetics is required with an Advanced degree (e.g. MS, MPH, PharmD; or worldwide equivalent from an accredited institution) in a human health, regulatory compliance or management of operations related field, with sound knowledge of product vigilance operations experience. Marketed product safety for medicinal products and/or cosmetics industry experience is preferred. Expert level knowledge and hands-on experience in individual case safety report processing, coding, documentation, and submission to health authorities is required. Advanced level understanding of international pharmacovigilance regulations is required. Demonstrated success in global operations, team and people management; insight and examples of application of management skills required to lead global, outsourced operations is required. Advanced level working knowledge of safety databases to identify inefficiencies or the need for system enhancements; in particular, experience in SCEPTRE and/or ARGUS safety systems is preferred. Excellent written and verbal communication skills in English is required. Demonstrated ability to create or improve safety case management and reporting operations is preferred. Experience with Consumer Medicinal Product safety, medical affairs, clinical research, or regulatory affairs is preferred. This position can be remote anywhere in the U.S. Up to 30% International Travel is required for this position.
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
Primary Location:North America-United States-Pennsylvania-Horsham
Other Locations:North America-United States
Organization: Johnson & Johnson Consumer Inc. (6071)
Job: Drug & Product Safety Operations
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.
Associate Director, Product Vigilance Operations, Consumer Medicinal Products-0962131104
Description
Johnson & Johnson Consumer Products Company, a division of Johnson & Johnson Consumer Companies, Inc., is recruiting for an Associate Director, Product Vigilance Operations, Consumer Medicinal Products, in Horsham, PA. This position can be remote anywhere in the U.S.
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 Associate Director, Product Vigilance Operations (AD, PVO) for Consumer Medicinal (CM) products is the senior pharmacovigilance operations expert and supervisor of other Product Vigilance Operations (PVO) staff in the case management and regulatory reporting of adverse event reports for the medicinal products of the Johnson & Johnson Family of Consumer Companies that are managed in the SCEPTRE safety system.
The AD, PVO-CM is accountable for the adverse event case management and regulatory reporting activities of Consumer Medicinal products. The primary accountability of the AD, PVO-CM is to establish and oversee end-to-end adverse event case management and reporting processes and ensure compliance with regulatory reporting requirements worldwide and departmental Standard Operating Procedures (SOP). As needed, the AD, PVO-CM leads cross-functional governance teams to ensure strategic alignment of priorities among key business stakeholders; manages vendor activities to ensure deliverables are met as defined in the supplier agreement; monitors key performance indicators to identify and implement process efficiencies and quality improvements; and, coordinates staff training and controlled document development to ensure consistent, standardized processes are in place. The AD, PVO-CM provides subject matter expertise and technical guidance on safety database functional requirements and enhancements to meet emerging global regulatory requirements and implementation of a global adverse event case management solution; monitors compliance metrics; and, implements corrective and preventative actions to remediate non-conformance issues.
This position will directly or indirectly oversee all pharmacovigilance operations staff involved in case processing and reporting for consumer medicinal products. Close working relationships (involving several time zones) with the Associate Director Pharmacovigilance Physicians for Consumer Medicinal Products, with management and staff of the OCMS Center for Global Safety in Manila, and safety service providers in Asia Pacific; as well as with the Qualified Person for Pharmacovigilance (QPPV) Consumer, and Safety Compliance leadership are critical. Interactions with medical and regulatory staff of Operating Companies and with colleagues responsible for Safety Informatics, Surveillance, Aggregate Reporting, and Decision Analytics, as well as the Consumer Care Center, Regulatory Affairs and Quality Assurance are expected to occur regularly.
Qualifications
A minimum of seven (7)+ years of direct or related experience in marketed product safety for medicinal products, medical devices and/or cosmetics is required with a Bachelors Degree in a human health, regulatory compliance or management of operations related field, with sound knowledge of product vigilance operations experience OR five (5) + years of direct or related experience in marketed product safety for medicinal products, medical devices and/or cosmetics is required with an Advanced degree (e.g. MS, MPH, PharmD; or worldwide equivalent from an accredited institution) in a human health, regulatory compliance or management of operations related field, with sound knowledge of product vigilance operations experience. Marketed product safety for medicinal products and/or cosmetics industry experience is preferred. Expert level knowledge and hands-on experience in individual case safety report processing, coding, documentation, and submission to health authorities is required. Advanced level understanding of international pharmacovigilance regulations is required. Demonstrated success in global operations, team and people management; insight and examples of application of management skills required to lead global, outsourced operations is required. Advanced level working knowledge of safety databases to identify inefficiencies or the need for system enhancements; in particular, experience in SCEPTRE and/or ARGUS safety systems is preferred. Excellent written and verbal communication skills in English is required. Demonstrated ability to create or improve safety case management and reporting operations is preferred. Experience with Consumer Medicinal Product safety, medical affairs, clinical research, or regulatory affairs is preferred. This position can be remote anywhere in the U.S. Up to 30% International Travel is required for this position.
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
Primary Location:North America-United States-Pennsylvania-Horsham
Other Locations:North America-United States
Organization: Johnson & Johnson Consumer Inc. (6071)
Job: Drug & Product Safety Operations
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.