Pharmacovigilance Associate Job at Breckenridge Pharmaceutical, Berkeley Heights, NJ

cXYydE55OUJ5Y3UvREtScUFmMnh2eFJxdHc9PQ==
  • Breckenridge Pharmaceutical
  • Berkeley Heights, NJ

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

At Breckenridge Pharmaceutical Inc, we take pride in being an equal opportunity employer. We are committed to creating an inclusive workplace and do not discriminate based on race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status, or any other characteristic protected by law. Employment decisions are made based on individual qualifications, merit, and the needs of the business.

Beyond the base salary, Breckenridge Pharmaceutical Inc. provides a comprehensive and competitive total rewards package. This may include annual bonuses, health benefits such as medical, dental, and vision insurance, life insurance, a 401(k) plan with company matching and favorable vesting terms, paid holidays and vacation.

Job Tags

Holiday work,

Similar Jobs

Walker Warner

Project Manager for Architecture Firm Job at Walker Warner

 ...with project consultants & contractors Lead and develop junior team members in the production, organization and coordination of the BIM model and drawing sets as required for presentations, agency approvals and construction Coach and mentor junior staff, share... 

Avid Technology Professionals

Software Engineer 1 Job at Avid Technology Professionals

Seven (7) years' experience as a SWE, in programs and contracts of similar scope, type, and complexity is required. Bachelor's degree in Computer Science or related discipline from an accredited college or university is required. Four (4) years of additional SWE experience... 

TWC

Commercial Property Manager Job at TWC

 ...Job Description Job Description Department: Property Management, Asset Services Division Directly Reports to: Regional Property Director General Overview The Commercial Property Manager leads with vision and accountability, overseeing the daily operations... 

VIGI Retail Solution

Motion Designer Job at VIGI Retail Solution

 ...performance and enable consumers to enjoy a seamless, effortless lifestyle.Overview:If you are a passionate and highly collaborative Motion Designer, then we want you on our team. We are developing the next generation of products for smart home and networking. You will be... 

Delaware North

Laundry Worker, Holiday Inn Squire Resort Job at Delaware North

 ...opportunity Delaware North Parks and Resorts is hiring a seasonalLaundry Worker to join our team at Holiday Inn Squire Resort in Tusayan,...  ...members Basic math skills Laundry worker experience in a hotel or other high-volume location is beneficial No experience or...