Manager, Global Pharmacovigilance Aggregate

2 meses atrás

São Paulo SP, Brasil Kenvue Tempo inteiro

Description

**Manager, Global Pharmacovigilance Aggregate Reporting**

This position reports into the Associate Director, GARRM Team Lead and is based in Sao Paulo, Brazil.

**Who we are**

At Kenvue, we realize the extraordinary power of everyday care. Built on over a century of heritage and rooted in science, we’re the house of iconic brands - including NEUTROGENA®, AVEENO®, TYLENOL®, LISTERINE®, JOHNSON’S® and BAND-AID® that you already know and love. Science is our passion; care is our talent. Our global team is made by 22,000 diverse and brilliant people, passionate about insights, innovation and committed to deliver the best products to our customers. With expertise and empathy, being a Kenvuer means to have the power to impact life of millions of people every day. We put people first, care fiercely, earn trust with science and solve with courage - and have brilliant opportunities waiting for you Join us in shaping our future-and yours.

**Role reports to**: Associate Director, GARRM Team Lead

**Location**: Sao Paulo, Brazil

**Travel %**:10

**What you will do**

Key Responsibilities
- Ensure timely, quality reports/safety analyses related to core deliverables as appropriate:

- Collaborate with GRASP, QPPV (where applicable), and other stakeholders on strategy development
- Provide oversight of staff involved in aggregate reporting
- Develop quality systems and procedures for the aggregate analysis and reporting of adverse effects related to Consumer products, to assure regulatory compliance with company standards and regulatory requirements
- Initiate/Conduct/Oversee searches of internal and external databases
- Perform management review of all vendor-produced materials (e.g. draft reports and assessment responses); and/or lead aggregate safety analysis and case level review
- Author, contribute, and coordinate the preparation of core safety deliverables
- Prepares global aggregate reports for local authorities
- Ensure compliance (quality, procedures, regulations, consistency) and commitments (e.g., Pharmacovigilance Agreements (PVAs), assessment reports) are met, where applicable
- Partner with vendor to develop reports/deliverables
- Develop and maintain global pharmacovigilance aggregate reporting processes and procedures in compliance with regulatory requirements.
- Lead and manage a team of pharmacovigilance professionals to ensure timely and accurate submission of aggregate reports.
- Collaborate with cross-functional teams to ensure timely and accurate data collection and analysis for aggregate reporting.
- Stay up-to-date with regulatory changes and industry trends related to pharmacovigilance aggregate reporting and implement necessary changes to processes and procedures.
- Develop and maintain systems, tools and processes for drug safety operations.
- Participate and/or lead cross-functional training of relevant stakeholders and colleagues.
- Act as product or process Subject Matter Expert (SME) during audits/inspections.
- Daily management of vendor activities and responsibility for compliance with SOPs/WIs, global regulations/guidelines by either onsite or offshore resources.
- Performs training, onboarding, and oversight of offshore vendor.
- Participate or lead department and/or cross-functional initiatives.
- Contributes metrics and ensures quality, compliance, and timeliness of aggregate safety reports.

Qualifications

**What we are looking for**

Required Qualifications
- Bachelor’s degree required (health/life sciences field)
- 5 years of experience in the pharmaceutical or related industry with 2 years of experience in Pharmacovigilance
- Proven experience working in matrix environment and cross-functional teams
- Comprehensive clinical/medical writing experience
- Strong English verbal and written communication skills
- Strong knowledge of global pharmacovigilance regulations and guidelines (i.e., ICH, GVP, etc.).
- Ability to work collaboratively with cross-functional teams.
- Strong analytical and problem-solving skills.

Desired Qualifications
- Advanced degree (e.g., MS, MPH, MSN, PharmD, RPh, PhD, etc.) preferred
- Strong leadership and presentation skills.
- Experience in developing and implementing drug safety policies and operating procedures.
- Ability to work in a fast-paced environment and manage multiple projects simultaneously.
- SME with in-depth product knowledge of assigned products; knowledge and hand-on experience in aggregate reports writing and compliance management.
- In-depth working knowledge of AE safety databases to identify system enhancements and efficiencies.

**What’s in it for you**
- Competitive Benefit Package*
- Paid Company Holidays, Paid Vacation, Volunteer Time, Summer Fridays & More
- Learning & Development Opportunities
- Employee Resource Groups
- This list could vary based on location/region
- Note: Total Rewards at Kenvue include salary, bonus (if applicable) and benefits. Your Talent Access Partner will be able to sha

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