Empregos atuais relacionados a Pharmacovigilance Auditor - Sao Paulo - Johnson & Johnson

Johnson & Johnson is currently recruiting for a Pharmacovigilance Auditor - Lead Specialist LATAM (New Consumer Health Company). This position may be located in Sao Paulo, Brazil; Sao Jose Dos Campos, Brazil; Guelph, Ontario, Markham, Ontario, Fort Washington, PA; Skillman, NJ or Remote.

Caring for the world, one person at a time has inspired and united the people of Johnson & Johnson for over 125 years. We embrace research and science - bringing innovative ideas, products and services to advance the health and well-being of people.

With $82.1 billion in 2020 sales, Johnson & Johnson is the world's most comprehensive and broadly based manufacturer of health care products, as well as a provider of related services, for the consumer, pharmaceutical, and medical devices markets. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion people every day, throughout the world.

If you have the talent and desire to touch the world, Johnson & Johnson has the career opportunities to help make it happen. Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer. Johnson & Johnson is the world's most comprehensive and broadly-based healthcare Company, touching the lives of nearly a billion people every day. Our Family of Companies throughout the world compete in consumer, pharmaceutical and medical devices & diagnostics markets and have the skills and resources to tackle the world's most pressing health issues.

The Bioresearch Quality & Compliance (Q&C) Pharmacovigilance Auditor - Lead Specialist independently leads the planning, conduct, and reporting of routine/non-routine Good Pharmacovigilance Practice (GVP) audits/assessments and supports inspections of the J&J Consumer sector worldwide, including J&J Consumer Local Operating Companies, partners and service providers. These audits/assessments/inspections provide an independent quality assessment to ensure compliance with appropriate regulations, SOPs, processes, etc. as they pertain to company-sponsored R&D and post-marketing pharmacovigilance activities, within the regions (Americas, Europe Middle East & Africa (EMEA), Asia Pacific). Also contributes to or may lead to other compliance and quality activities, as assigned.

**Job and Responsibilities**:

- Independently lead the planning, conduct, and reporting of BRQC routine and non-routine audits of activities, data, internal facilities, and processes in GVP to assure adherence to corporate policies, internal standards/requirements and compliance with applicable regulatory requirements.
- Non-routine audits include Due Diligence, for cause audits, and cross-functional, system/service provider audits as defined by the scope.
- May support other auditors in planning, conducting and reporting of audits. Ensures the relevant standard procedures, diagnostic tools, and audit plans are fully understood and applied in audit activities.
- Participates in regulatory inspections in core and supporting roles. Assists in the preparation and delivery of training materials.
- Advises and contributes to coaching. Completes training requirements in a timely manner to ensure inspection readiness at all times.
- Takes an active role in projects as assigned by supervisor and interacts with key stakeholders as appropriate.
- Meets priorities, checkpoints, and timelines for all aspects of work and projects to achieve adequate progress.
- Provides expertise and knowledge to less experienced auditors, Business Partners, and the core business sector on quality and compliance processes/procedures.
- Interprets and applies regulations/ policies to issues of moderate complexity, when required.

**Qualifications** Position Requirements**:

- Minimum 6 years of experience in the pharmaceutical industry
- Expertise in Good Pharmacovigilance Practice
- Comprehensive knowledge of the drug development process, R&D practices, regulatory quality requirements, and/or post-marketing surveillance of drugs, medical devices
- Knowledge of procedural and records management requirements in a regulated industry
- Prior pharmaceutical, consumer personal products, and quality/compliance-related experience
- Knowledge of auditing techniques
- Must have excellent communication skills and be fluent in written and spoken English
- Must be a team player, organized and detail-oriented, and possess sound problem-solving conflict resolution, and good negotiating skills
- Must be able to work with a high level of independence and be able to train/coach others with regard to the interpretation of regulatory requirements and compliance activities, and project management to ensure the timely and accurate completion of quality & compliance activities
- Bachelor’s Degree or equivalent

**Preferred Requirements**:

- Experience working in a Quality or Regulatory organization
- Expertise in one or more spe