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Director, US Commercial Pharmacovigilance-Local Safety Officer
3 months ago
DescriptionJohnson & Johnson Innovative Medicine (JJIM) is recruiting for a US Local Safety Officer (LSO) in the Commercial Pharmacovigilance team to work in either in Titusville, NJ or Horsham, PA. At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal.Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.Learn more at The Local Safety Officer (LSO) has primary responsibility for the oversight of JJIM operational drug safety activities for post-approval products. The LSO is an employee of the local operating company and should be skilled in strategic planning and direction as well as operational execution in support of commercial product safety, under the oversight of the Senior Director, Commercial Pharmacovigilance and REMS within Scientific Affairs.The LSO is a strong leader skilled at collaboration, and partners with Global Medical Safety (GMS), J&J business/functional units, and contractual 3rd parties and suppliers to identify, evaluate and communicate safety operational issues that are relevant to assigned products. The LSO is accountable for internal quality systems that maintain compliance with regulations, policies, and procedures, and also ensures processes are aligned with US Janssen pharmacovigilance (PV) strategy and changes in corporate and/or regulatory requirements. Influencing without direct management responsibility as well as an in-depth knowledge of U.S. drug safety regulations and best practices in PV are key requirements for this position. Knowledge of worldwide safety regulations is helpful.The LSO may have additional responsibilities, where applicable, as defined by national law. Although components of the LSO role may be delegated with appropriate documentation, responsibility for the management of the US Pharma sector and overall requirements cannot be delegated.To be effective, the LSO is responsible for the development of employees under their direction, and providing an environment that encourages the company’s commitment to equal employment opportunity and the value of a diverse workforce.Key Responsibilities:Oversight of locally generated adverse event (AE) information, including product quality complaints (PQC), as well as local reporting of relevant information to regulatory agencies. This includes the collection, review and forwarding of applicable locally collected AE information to Global Medical Safety (GMS); the follow-up of outstanding AE information from local reporting sources; and reporting to local regulatory agencies all required AE information for locally applicable products.Accountable internally for ensuring that JJIM US and its agents meet all timelines for management of safety information and submission of individual or aggregate reports.Reconcile compliance data provided by GMS and take appropriate corrective actions.Partner with non-US LSOs, Commercial Quality/Product Quality Vigilance, and Scientific Affairs leadership to ensure consistency and continuity between Sector standards, Global, Cross-Pharma and local operating procedures and compliance with safety reporting regulatory requirements.Assess relevant safety-related information and processes for applicability across JJIM US companies, ensure the awareness of changes in regulations and evaluate the impact on local processes, provide technical and strategic input, and contribute to local Quality activities to maintain compliance with local laws & regulations.Partner with Global, local, and 3rd party business units, including Supply Chain, Scientific Affairs and Commercial partners to manage AEs, PQCs and safety-related information according to Good Practice (GxP) and JJIM processes.Develops and maintains an effective oversight model for internal partners to monitor PV compliance.Where appropriate, provide support/input to the safety aspects of local study protocols for both Medical Affairs and Real-World Evidence studies, including Collaborative and Investigator-Initiated Studies (IIS).Conduct ongoing assessment of GMS and other safety-related controlled documents for applicability of content/subject matter by business/functional unit.Ensures training of employees, contractors, consultants on safety-related controlled documents as applicable (e.g., J&J Global AE/PQC Awareness training).Ensures local safety officer designees and US Commercial Pharmacovigilance team/designees are trained on role-specific core curricula. Reviews/approves applicable curricula.Maintain an appropriate system of PV and Risk Management activities.QualificationsEducation:BA/BS in life sciences required; M.S., R.N., PharmD or similar preferredExperience and SkillsRequired:Detailed knowledge of PV regulations, pharmaceutical drug development processes and post-marketing obligations including AE and PQC managementAdept at navigating in a sophisticated matrix environment to accomplish objectivesExperience with FDA inspections and PV-related responses to Requests for InformationProficient knowledge and experience with regulatory (FDA) aspects of prescription drug development end-to-end, including experience with various types of US submissions· Excellent oral and written communications skills - English is required.· Ability to travel domestically up to 10%, which may include overnight travel as determined by customer and business needs.Preferred:Familiarity with risk management program design and assessment for U.S. and North American patient safety programs, including REMSAbility to influence within function, cross-functionally, and globallyExcellent communication, interpersonal, negotiation, and problem-solving skillsThe anticipated base pay range for this position is $160,000 to $265,000 The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/performance year. Bonuses are awarded at the Company’s discretion on an individual basis.Employees may be eligible to participate in Company employee benefit programs such as health insurance, savings plan, pension plan, disability plan, vacation pay, sick time, holiday pay, and work, personal and family time off in accordance with the terms of the applicable plans. Additional information can be found through the link below. Information on benefits can be viewed by following this link: Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.Job Field: PharmacovigilanceOrganization: Janssen Scientific Affairs, LLC (6120)Travel: Yes, 10 % of the Time
