Manager, Pharmacovigilance (PV) Risk Management
Posted on Apr 6, 2021 by Johnson & Johnson
Janssen Research & Development, LLC., is recruiting for a Manager, Pharmacovigilance (PV) Risk Management within the BioResearch Quality & Compliance (BRQC) organization located in the United States. Preferred locations include near a J&J US hub: Chesterbook, PA; Titusville, NJ; Horsham, PA; Skillman, NJ; Raritan, NJ; California. May consider other remote US location.
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 Research & Development, LLC discovers and develops innovative medical solutions to address important unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. Please visit for more information.
The Manager, Pharmacovigilance (PV) Risk Management will utilize demonstrable PV knowledge and expertise to enable corporate R&D objectives through risk management and quality planning across the PV system and across applicable sectors. He/she will collaborate with other Quality and business functions in support of the identification of risks to quality and compliance and implementation of appropriate mitigation actions across the Pharmacovigilance systems.
With minimal supervision by his/her line manager the Manager, PV Risk Management is responsible for defining and executing on Quality Working Groups, as part of the PV Process Risk Management framework to proactively identify and facilitate mitigation of significant risks across the PV System, to assure Johnson & Johnson remains in compliance with local health authority and/or general company, PV agreements, industry standards, national and international regulations.
Manage the execution of the PV Process Risk Management framework in close collaboration with key business partners to support R&D operations business-critical PV related activities. Key activities include leading or assisting in:
Quality Working Groups in the identification, evaluation and prioritisation of PV risks, documenting meeting minutes
Collaboration with PV business partners to drive development of robust risk mitigation activities to manage identified risks and assure all actions are driven to resolution, to bring down the risk
Development of KRIs to continuously monitor PV risks and the effectiveness of risk mitigations.
Evaluate pre-defined areas of risk and/or identify new areas of risk.
Monitors ongoing risks and mitigations on an ongoing basis, with quarterly reviews documented in the risk management system.
Lead the creation of quality data analytics to generate actionable insights. Contextualise data driven insights to stakeholders and provide quality consultancy.
Present significant risks at the PV Risk Oversight Forum (ROF) meetings
Collaborate with BRQC Regulatory Compliance to support health authority inspections, readiness activities and post-inspection commitments to address requests/commitments, as assigned by CSA leadership
Support other duties as assigned (eg CAPA development, issue resolution etc.)
Drive prompt management of significant PV quality events in collaboration with relevant BRQC and PV leadership and business partners including but not limited to formal escalation, support of CAPA development and/or overseeing execution of risk management activities
The Manager PV Risk Management will execute their duties in such as way as to ensure that across Janssen and Consumer Local Safety Units, all applicable international and associated global standards are implemented to a consistent standard and maintained as such. This role will also ensure that standards for inspection readiness are translated to business partners responsible for processes across the PV system and to support both high standards of compliance and standardised execution.
Additional responsibilities include:
Participates in CSA, cross-BRQC Janssen, cross-functional, or cross-sector working groups to develop or refine processes, tools, and systems that support key activities.
Trains or mentors peers and new employees, as needed.
Bachelor of Science (BSc) degree in a life science, natural science or business is required. An advanced degree (MD, PhD, MSc, or PharmD) is preferred
Minimum 8 years professional experience in Pharmacovigilance (PV) and/or quality risk management required.
Experience in and/or knowledge of risk management in a regulated industry is required; Recognized certifications are preferred (eg, ISO 31000, ICH Q8, Q9, Q10, etc.)
Knowledge of the global drug development process, including current global PV regulations, is preferred
Ability to analyze and interpret data, derive insights, and determine root cause to adjudicate issues in the research and development process required
Strong written, visual, and verbal communications with an ability to tailor communications to peers, business partners and senior management required
Ability to resolve conflicts, build consensus, influence and negotiate are required
Ability to navigate relationships and tasks with diplomacy and tact are required
Ability to drive results through credibility, influence and leadership by example. Desired attributes include self-awareness, adaptability, attention to detail, and a high capacity for teamwork. Strong networking and relationship building skills are required.
Ability to drive change management with peers, management and business partners is required
Disciplined approach to defining and addressing problems is required
Organization, prioritization and time management skills are required
Ability to create an open, inviting and creative environment is required
Ability to work in a global environment is required
Experience working with multidisciplinary and cross functional leaders from R&D, Medical Safety, Regulatory and Quality functions preferred
Proactive strategic thinker with strong problem solving skills is required
Strong blend of both strategic and tactical approaches to quality and business objectives required
Up to 25% domestic and international travel may be required
Work location is flexible if approved by the Company except that position may not be performed remotely from Colorado.
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.