Affiliate Pharmacovigilance Manager at Eli Lilly and Company

Sao Paulo, Sao Paulo, Brazil

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Not SpecifiedCompensation

Mid-level (3 to 4 years), Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, HealthcareIndustries

Requirements

Knowledge of national pharmacovigilance regulations in Brazil and applicable local/global Lilly standards and procedures
Ability to provide technical support to business operations in Lilly Brazil
Capability to support activities and projects as needed

Responsibilities

Oversee receipt, processing, follow-up, and expedited reporting of adverse event cases from Brazil
Provide quantitative/qualitative metrics to Brazil leader and technical support to staff leaders
Review and approve adverse event cases for submission to local/national regulatory authorities
Liaise with affiliate departments (e.g., Customer Relationship, Product Complaint Areas) to share pharmacovigilance requirements and align processes
Review, classify, and approve technovigilance investigational reports for submission to regulatory authorities
Communicate with Regulatory Affairs to align milestones for PSUR/PBRER submissions
Oversee calendar for PSUR/PBRER submissions per Brazilian regulations
Liaise with global surveillance teams to ensure timely availability of documents for local submissions
Coordinate assemblage and translation of PSUR/PBRER documents for regulatory compliance
Communicate with Regulatory Affairs to align milestones for RMP/RMiP submissions
Liaise with global surveillance teams for documents needed for RMP/RMiP local submissions
Discuss additional risk minimization activities with BRC leader and support implementation
Coordinate assemblage and translation of RMP/RMiP documents for regulatory compliance
Liaise with Medical Affairs to identify local scientific journals of interest
Oversee literature search in Brazil for adverse events, ensuring local process compliance
Coordinate/provide pharmacovigilance training to affiliate personnel and third-party organizations
Support affiliate business operations (e.g., updating safety language in contracts, reviewing/approving local Tier A Market Research projects)
Review and archive compliance metrics (e.g., for expedited reporting, PSUR/PBRER)

Skills

Pharmacovigilance

Adverse Event Management

Regulatory Reporting

Case Processing

Metrics Analysis

Regulatory Compliance

Process Alignment

Eli Lilly and Company

Develops and delivers prescription medicines globally

About Eli Lilly and Company

Eli Lilly and Company is a global pharmaceutical company that focuses on discovering, developing, and delivering medicines to improve health. The company has a long history of scientific achievements, including the creation of insulin, the first life-saving treatment for diabetes. Lilly's operations involve extensive research and development to create new medications and enhance existing ones, ensuring they are safe and effective. Their products are primarily prescription medicines sold to healthcare providers for various medical conditions, including diabetes, cancer, and pain management. What sets Lilly apart from its competitors is its strong commitment to ethical practices and the protection of its products from counterfeiting. The company's goal is to enhance lives through innovative medical solutions while maintaining high standards of quality and ethics.

Indianapolis, IndianaHeadquarters

1876Year Founded

$1,180.1MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

Risks

Competition from Novo Nordisk's Ozempic may impact tirzepatide's market share.

Potential construction delays in Indiana could affect GLP-1 drug production timelines.

Regulatory challenges may hinder Kisunla's expansion in new Alzheimer's markets.

Differentiation

Eli Lilly's rich history includes the first life-saving insulin treatment.

Lilly's strategic partnerships enhance its position in neurodegenerative disease treatments.

FDA approval of Zepbound opens new therapeutic markets for sleep disorder treatments.

Upsides

Lilly's $9 billion complex in Indiana boosts GLP-1 drug production capacity.

Kisunla's approval in China expands Lilly's Alzheimer's treatment market in Asia.

Collaboration with EVA Pharma enhances Lilly's reputation as socially responsible.

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