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Associate Director, US Pharmacovigilance - 2406194496W

Description

At Johnson & Johnson Innovative Medicine 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 https://www.jnj.com/.

Diversity and inclusion are central elements of the shared culture across the Johnson & Johnson Family of Companies. Attracting, developing, and retaining a workforce that reflects the diversity of our customers and communities is essential to our success. We are committed to providing a respectful, inclusive, and accessible work environment where all employees can achieve their potential.

The Associate Director, US Pharmacovigilance is responsible for overseeing the Pharmacovigilance (PV) operations for the Johnson & Johnson Innovative Medicine (J&J IM) US Commercial Operating Companies (OpCo) in support of the US Local Safety Officer (LSO) / US Pharmacovigilance Officer (PVO).

Under the direction of the LSO/PVO, this position will be responsible for leading various projects to drive audit and inspection readiness and support key improvement initiatives.

Develop and maintain constructive working relationships with business partners in support of initiatives and to accomplish company goals.

Responsible for the development of all employees under their direction by supporting the development of Human Resources Planning (HRP) programs including management development and training to meet current and future business needs. Provide an environment which encourages the company’s commitment to equal employment opportunity and the value of a diverse workforce.

Responsibilities:

• Develops strategic end-to-end processes and innovative ideas to address compliance risks to business; leads change within the US OpCo to ensure business compliance.

• Develops key PV metrics to facilitate LSO/PVO oversight of US OpCo, IM Office of the Chief Medical Officer (OCMO), & Product Quality Vigilance (PQV) compliance performance; monitors PV reporting compliance, addressing any trends identified.

• Drives opportunities to leverage technology and/or systems integrations to increase accuracy and efficiency or to address changing regulatory/business requirements.

• Leads operational PV activities conducted by the US Pharmacovigilance (USPV) team, providing guidance and motivation, ensuring compliance and efficiency.

• Drives innovation, challenges status quo and leads projects setting project goals, identifying requirements, and driving timely completion of deliverables.

• Establishes relationships with global business partners [e.g. IM OCMO, Commercial Quality North America –Document and Learning Management (CQ NA DLM), Procurement] to drive compliance with PV requirements for the US OpCo.

• Supports the LSO/PVO oversight of local risk minimization and REMS activities, ensuring compliance with internal policies and procedures.

• Supports the US LSO/PVO in audit and inspections; supports the activities related to closure of internal and external PV audit and inspection records.

• Partners with Commercial Quality to assess potential PV non-conformances; initiates Quality Investigation (QI) records identifying record owners and ensures thorough documentation and timely completion of USPV QI records.

• Responds to ad hoc requests and situations requiring PV expertise.

• Primary Contributor to the Pharmacovigilance System Master File (PSMF) Annexes A & C and B.

Collaborates with LSO and other stakeholders, including non-US LSOs, Local Quality Executive, and JSA leadership to:

• Conducts ongoing assessment of IM OCMO and other safety-related controlled documents for applicability of content/subject matter by business/functional unit across the US Pharm Op Co.

• Collaborates with DLM to develop/update procedural documents, LIDs and trainings materials.

• Develops strategy and training plans for all US OpCo PV trainings in collaboration with DLM.

• Ensures compliance with validated systems by monitoring change releases, updating USPV user requirements and managing user acceptance testing for change releases.

• Maintains the USPV training curricula.

• Responsible for Business Continuity Plan for USPV

• Assists Local Safety Officer in setting team strategy; establishes and delegates operational goals, objectives and assignments; communicates objectives to staff.

• Supports US Commercial Pharmacovigilance budget and resource requirements.

• Provides direction and prioritization as it pertains to daily workload activities and projects, communicates expectations, provides feedback and performs evaluation on final output and key deliverables.

Responsible for the development of all employees under their direction by supporting the development of Human Resources Planning (HRP) programs including management development and training to meet current and future business needs.

Qualifications

This role requires a Bachelor’s of Science Degree.

• Job requires detailed knowledge of the PV regulations, pharmaceutical drug development processes and post-marketing obligations including product quality complaint management.

• Adept at navigating in a matrix environment to accomplish objectives.

• Strong written and oral communication and presentation skills.

• 7 years’ experience in pharmaceutical industry compliance related and/or safety related function.

• Prior people management and leadership experience is required.

• Experience interfacing with auditing and compliance organization

• Strong organizational and interpersonal skills; project management skills preferred

• Familiarity with J&J technology systems/tools (e.g., Global Safety Database, Salesforce.com)

The expected compensation range for this role: $135,000-$232,000

At Johnson & Johnson, we’re on a mission to change the trajectory of health for humanity. That starts by creating the world’s healthiest workforce. Through cutting-edge programs and policies, we empower the physical, mental, emotional, and financial health of our employees and the ones they love.

Information on benefits can be viewed by following this link: https://www.careers.jnj.com/employee-benefits

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.

Primary Location NA-US-New Jersey-Titusville

Other Locations NA-US-Pennsylvania-Horsham

Organization Janssen Scientific Affairs, LLC (6120)

Job Function Pharmacovigilance

Req ID: 2406194496W