Manager, Safety Services (1 of 2) Job

Job description

Manager, Safety Services (1 of 2)-2631151123DescriptionJanssen Scientific Affairs, LLC, a Johnson and Johnson Company, is recruiting for a Manager, Safety Services to be based Horsham, PA.At the Janssen Pharmaceutical Companies of Johnson & Johnson, what matters most is helping people live full and healthy lives. We focus on treating, curing and preventing some of the most devastating and complex diseases of our time. And we pursue the most promising science, wherever it might be found. Janssen Scientific Affairs, LLC is dedicated to providing medical information and consultative support to the Janssen pharmaceutical companies.
We are Janssen. Our mission drives us. Our patients inspire us. We collaborate with the world for the health of everyone in it.
Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.
The Manager of Safety Services has responsibility for: Pharmacovigilance oversight to ensure the compliant management of internal and external organizations that are required to report adverse events and product quality complaints to ensure that Janssen Scientific Affairs supported products are safe and effective for human use; Managing effective relations with internal and external partners to drive regulatory, legal and corporate compliance regarding multiple aspects and components of a quality safety reporting system (e.g. appropriate contract language, vendor training, reporting reconciliation and program management); Maintenance of training materials for external partner training; Provide quality support to ensure compliance with policies and SOPs related to adverse event (AE) and product quality complaint (PQC) reporting for the US Commercial business; Ensuring compliant program management for safety reporting in accordance with US and international reporting regulations, Standard Operating Procedures (SOPs) and safety processing guidelines. Develops and ensures that compliance metrics demonstrate oversight. Implementing additional oversight measures to monitor compliance.
Additionally responsibilities: Developing programs and processes to ensure proactive oversight of external partner programs to ensure that processes are in place for both AE and PQC reporting; Monitoring timely submission of Janssen Scientific Affairs sponsored clinical activities managed by external partners individual case safety reports to the Company drug safety units and takes appropriate action for non-compliance; Initiating effective solutions for potential gaps; Perform trend analysis; identifies problems and opportunities for continuous improvement of external partner safety reporting processes. Leverages existing and new technology to assist in solution development; Initiate deviation memos, event descriptions, and corrective action plans in an effective and timely manner, appropriately maintains all documentation, and follows plan through completion; Drive corrective and preventative actions to address audit and inspection findings related to external partner safety reporting and ensures that responses are executed compliantly.
The Manager’s oversight includes: The assessment of a potential safety compliance risks associated with clinical activities sponsored by the US commercial operating companies; Developing programs to prevent non-compliant issues from arising; Effectively partnering with Operating Companies, Medical Affairs, Market Research, Health Economics and Outcomes Research and Scientific Affairs teams to ensure that all clinical activities are compliant with the relevant safety reporting procedures, guidelines and processes; Managing risk associated with vendors conducting clinical activities on behalf of US commercial operating companies and Janssen Scientific Affairs receiving adverse events by using innovation to improve areas of deficiency; Ensures Janssen Scientific Affairs procedural control documents are in conformance with relevant J&J procedural documents including J&J Corporate and cross-pharma policies, standard operating procedures, guidance documents and work instructions; Manages multiple projects simultaneously (works with external service providers and third-party safety agreement partners); Maintains safety compliance training materials for all Janssen Scientific Affairs staff, internal and external associates and vendors including contractors responsible for collecting and handling safety information; Designs and delivers training programs associated with pharmacovigilance and safety activity; Supports Global Medical Safety (GMS) and other business partners in pharmacovigilance activities as appropriate.
QualificationsA minimum of a Bachelor’s Degree in Medical /Pharmacy/Life Sciences/Nursing and a minimum of 5+ years of pharmaceutical experience with related functions are required. Prior experience in a safety compliance role is required (i.e.
- prior experience with regulatory mandated processes for handling adverse events and product quality complaints). Experience interfacing with auditing and compliance organization is preferred. Knowledge of the drug safety regulations and reporting process is required.
Knowledge of Good Clinical Practices (GCP) related to clinical safety documentation and reports is preferred. Knowledge of Janssen Scientific Affairs supported products is preferred. Excellent communication skills and influencing skills are required. The ability to interface with multiple parties in development and implementation processes is required. Strong knowledge of U.S. adverse event reporting regulations is required. Excellent planning, organizational and interpersonal skills is required. Familiarity with Customer Response Management systems is preferred.
Travel may be up to 5%.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 NAJ2W:BioSpaceJ2W:BioTech_JCJ2W:AAPharmSJ2W:ASAJ2W:HireDiversityPrimary Location:North America-United States-Pennsylvania-HorshamOrganization: Janssen Scientific Affairs, LLC (6120)Job Function: Drug & Product Safety OperationsCertain 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, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law. EEO is the Law EEO is the Law GINA Supplement