Job Description

About the Company

Breckenridge Pharmaceutical develops and markets high-quality, added-value and cost-effective generic drugs in the United States. Our products are developed in the group’s own R&D facilities and through strategic partnerships with manufactures from around the world.

About the Role

The Pharmacovigilance Associate supports the company’s safety and pharmacovigilance responsibilities by processing adverse event reports, maintaining safety documentation, supporting literature surveillance, and assisting with regulatory compliance. This position plays a critical role in supporting and ensuring that the company's pharmacovigilance operations align with FDA requirements and supports business continuity as part of the long-term growth strategy.

Responsibilities

• Receive, review, and process adverse drug experience (ADE) reports from internal and external sources (e.g., healthcare providers, customers, literature, vendors).
• Document and code cases using MedDRA terminology and enter into the PV database.
• Ensure accurate and timely entry of safety data into PV databases.
• Assist in the preparation and submission of Individual Case Safety Reports (ICSRs) via FDA MedWatch, E2B gateway, or other regulatory systems.
• Maintain accurate and compliant PV case files and track follow-ups.
• Support generation and timely closure of adverse event complaints with proper documentation.
• Draft standard complaint response letters under supervision, as needed.
• Perform weekly literature reviews for safety signals and ADEs in alignment with PV SOPs.
• Document findings and assist with literature case processing and escalation.
• Assist with compiling information for aggregate reports such as Periodic Adverse Drug Experience Reports (PADERs).
• Support the preparation of safety sections for ANDA submissions and new product registrations.
• Maintain Safety Data Exchange Agreements (SDEAs) and ensure partner obligations are tracked and met.
• Assist in managing safety files, training records, and compliance documentation.
• Liaise with internal departments such as Regulatory Affairs, Quality, and Customer Service for safety-related inquiries.
• Support communication with external PV vendors, including literature screening partners and database service providers.
• Participate in internal PV training programs and stay current with FDA safety reporting requirements.
• Support the development and maintenance of Risk Management Plans (RMPs) and Risk Evaluation and Mitigation Strategies (REMS) for generic products, as needed.
• Participate in internal audits and inspections to ensure compliance with pharmacovigilance regulations and standard operating procedures, as needed.
• Contribute to the development and revision of PV procedures to align with current regulatory requirements.
• Perform other departmental activities related to updating trackers, labeling reviews and eCTD support.

Qualifications

• Bachelor's degree

Required Skills

• 1–2 years of experience in a PV, quality, regulatory, or related healthcare/pharma setting preferred.
• Familiarity with MedDRA coding, FDA MedWatch, and pharmacovigilance databases is a plus.
• Strong attention to detail, organization, and ability to manage timelines.
• Good communication and collaboration skills.
• Microsoft 365
• Windows
• Experience with eCTD software preferred, MSWord, Excel, Adobe Acrobat and other document processing software.

Preferred Skills

• Statistical analysis, ability to generate reports/ summary
• Critical thinking and problem-solving
• Knowledge of regulatory agencies and best practices
• Industry-specific technical knowledge

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