Affiliate Pharmacovigilance Manager

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Purpose:

The purpose of the Affiliate Pharmacovigilance Manager role is managing the pharmacovigilance processes and procedures of Lilly Affiliate in Brazil, in accordance with the national pharmacovigilance regulations and with the applicable local and global Lilly standards and procedures, and for providing technical support to the business operation in Lilly Brazil. The Affiliate Pharmacovigilance Manager may also support activities and projects.

Primary Responsibilities: This job description is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description. Consult with your supervision regarding your actual job responsibilities and any related duties that may be required for the position.

1. Management of adverse event cases in the Brazil

• Oversee the receipt, processing, follow-up, and expedited reporting of adverse event cases from Brazil.
• Provide quantitative / qualitative metrics to the Brazil leader and technical support to staff leaders.
• Review and approve adverse event cases that qualify for submission to local / national regulatory authorities.
• Liaise with other affiliate departments (e.g., Costumer Relationship and Product Complaint Areas), sharing pharmacovigilance requirements and aligning processes related to the receipt and submission of adverse event cases in Brazil.
• Review, classify and approve techno vigilance investigational reports that qualify for submission to local / national regulatory authorities.

2. Regulatory submission of Periodic Safety Update Reports (PSUR/PBRER)

• Communicate with Regulatory Affairs, aligning milestones for the submission of PSUR/PBRER.
• Overview calendar for submission of PSUR/PBRER, assuring dates and requirements are in accordance with Brazilian pharmacovigilance regulations.
• Liaise with global surveillance teams, assuring the documents required to local submissions are available on a timely manner.
• Coordinate assemblage and translation of documents, assuring PSUR/PBRERs are submitted in accordance to regulatory requirements.

3. Regulatory submission of Risk Management Plans (RMPs) and Risk Minimization Plans (RMiPs)

• Communicate with Regulatory Affairs, aligning milestones for the submission of RMPs.
• Liaise with global surveillance teams, assuring the documents required to local submission are available on a timely manner.
• Discuss additional risk minimization activities with the BRC leader (Associate Director/ Director), supporting elaboration and implementation in the affiliate as needed.
• Coordinate assemblage and translation of documents, assuring the RMPs/RMiPs are submitted in accordance to regulatory requirements.

4. Management of search for adverse events in local scientific journals

• Liaise with Medical Affairs to identify local scientific journals of interest.
• Oversee literature search in Brazil, assuring compliance to the local process.

5. Pharmacovigilance operation of Lilly Brazil

• Coordinate/provide pharmacovigilance training to affiliate personnel and third party organizations.
• Support affiliate business operation when required (e.g., updating safety language attachments for contracts with third party organizations, reviewing/approving local Tier A Market Research projects, etc.).
• Review and archive compliance metrics (for expedited reporting, PSUR and DSUR submissions).
• Monitor pharmacovigilance training requirements for roles involved in affiliate activities.
• Maintain/update the Detailed Description of the Pharmacovigilance System.
• Collect pharmacovigilance information for the Pharmacovigilance System Master File.
• Maintain/update the local Business Continuity Plan of the Pharmacovigilance Department.

6. Subject Matter Specialist for affiliate pharmacovigilance procedures and resources.

7. Support activities and projects important to Brasil and to the overall Patient Safety Organization.

8. Local pharmacovigilance related responsibilities

• Fulfill the regulatory requirements for Pharmacovigilance Officer and Technovigilance Representative in Brazil.
• Understand the roles and responsibilities of the European Union Qualified Person.
• As necessary, ensure appropriate delegation of specific tasks to appropriately qualified and trained Patient Safety staff and ensure appropriate backup coverage is in place in times of absence.

Minimum Qualification Requirements:

• Bachelor's degree (or higher) in a life sciences field or demonstrated equivalent experience
• Clinical knowledge of various disease states, human physiology and pharmacology
• Proven expertise in pharmacovigilance and understanding of Brazilian pharmacovigilance regulations and communication with Regulatory Authorities
• Clinical knowledge of various disease states, human physiology and pharmacology
• Demonstrated ability to identify issues within and across processes, develop and implement solutions
• Demonstrated leadership by influence, including ability to negotiate appropriately and effectively across teams
• Fluency in Portuguese and English (able to communicate effectively speaking or writing, in both languages)
• Basic computer skills.
• Permanent availability (as determined by the Pharmacovigilance legislation in Brazil).

Other Information/Additional Preferences:

• Previous experience authoring SOPs, establishing quality systems, and delivering training.

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