Sr. Pharmacovigilance Specialist

Overview

Why Us? At Par Health, we believe great healthcare is built on getting the essentials right. We’re looking for passionate, talented individuals who share our commitment to improving lives. With 4,000+ team members worldwide, we lead with pride and purpose—prioritizing quality and safety while fostering a culture of continuous improvement, accountability, and teamwork. Elevating the Essentials isn’t just our tagline, it’s the higher standard we live by every day.

Job Description Summary

The primary responsibility of the Senior (Sr.) Pharmacovigilance (PV) Specialist is to collect, accurately document, assess, code and process adverse event reports related to the marketed products monitored by the Par Health PV within the time frames established by Par Health PV and in compliance with global regulatory requirements as well as Safety Data Exchange Agreements. The Sr. PV Specialist will serve as a primary contact point and recipient for adverse events.

The role includes managing processing and reporting of serious adverse events received during Company-sponsored clinical trials. The Sr. PV Specialist may perform all pharmacovigilance activities or oversee PV vendors/CROs handling PV on behalf of Par Health. The Sr. PV Specialist will handle related safety inquiries for internal and external customers and will analyze safety data for Par Health pharmaceutical products.

The role involves establishing and maintaining positive relationships with PV stakeholders globally and domestically to ensure global PV compliance. The Sr. PV Specialist may undertake other tasks as needed and will be cross trained to handle other functions as deemed necessary.

Job Description

ESSENTIAL FUNCTIONS

NOTE: The Sr PV Specialist will either perform the essential functions or participate in oversight of those functions if handled by a PV vendor/CRO.

Responsibilities include:

• Collect and accurately document adverse event reports; triage incoming information for completeness, consistency and seriousness (including medical evaluation and assessment).
• Process adverse events in the Par Health Safety System, ensuring accuracy of event coding, assessment, medical history and laboratory data, and the written narrative.
• Review individual adverse event reports to ensure cases meet Par Health quality standards before submission to regulatory bodies and safety partners.
• Prepare and submit expedited reports to regulatory authorities, including obtaining appropriate medical review.
• Prioritize PV functions to meet regulatory authority and safety partner timelines.
• Review literature searches for case safety reports or relevant safety information and process as described in sections 4–6.
• Perform queries for adverse event reports as required (verbal, email, written).
• Ensure compliance with Safety Data Exchange Agreements with safety partners.
• Execute searches in the Par Health Safety System as required.
• Integrate newly acquired pharmaceutical products into MNK Par Health PV system.
• Provide support during regulatory inspections, safety partner audits, internal audits, etc.
• Compile data for Aggregate Safety Reports and manage the process and timelines for developing final Aggregate Safety Reports for Regulatory Affairs or other departments.
• Distribute PV data to Quality, Legal, Regulatory Affairs or other departments as needed.
• Elevate potential safety signals and alert appropriate management when needed.
• Initiate and coordinate investigations with Product Monitoring Department as necessary.
• Ensure proper adverse event handling, including reconciliation of events by Par Health Product Monitoring and Medical Information Departments.
• Attend seminars to stay current with global regulatory requirements and guidance on Pharmacovigilance and drug safety.
• Collaborate with Product Monitoring, Medical Information, Regulatory Affairs, International Regulatory, Clinical Operations, Sales, Legal, Marketing, Quality Assurance and other departments as needed.
• Participate in team activities related to safety, development or support of products.

DEPARTMENT SPECIFIC/NON-ESSENTIAL FUNCTIONS
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Other duties as assigned with or without accommodation. Maintain or hold an active…