Job Title: Pharmacovigilance (PV) Associate
Location: Remote
Department: EVERSANA
About EVERSANA:
At EVERSANA, we are driven by our vision to create a healthier world. With a team of over 7,000 employees globally, we work to deliver next-generation commercialization services across the life sciences industry. Our services help bring innovative therapies to market and support the patients who depend on them. We are a certified Great Place to Work, and our commitment to improving patient lives fuels everything we do. Our diverse team of employees contributes to building an inclusive culture that values innovation, collaboration, and a passion for improving healthcare.
Job Purpose:
The Pharmacovigilance (PV) Associate will support the client PV Department in processing and analyzing safety data from clinical trials and post-marketing reports. This individual will be a key team member responsible for case management, adverse event (AE) reporting, regulatory submissions, and providing ongoing support to the PV team to ensure compliance with regulations.
Key Responsibilities:
Adverse Event (AE) Case Management:
Adverse Event Reporting: Collect AEs from all sources, triage cases to determine reportability, and ensure accurate reporting of AEs in the safety database.
Independent Assessment: Assess seriousness, expectedness, and causality in accordance with regulatory guidelines and product reference safety information.
Data Entry: Enter accurate AE data into the client’s safety database with minimal supervision, ensuring completeness and consistency.
Coding: Independently code AEs using MedDRA and medications using WHODRUG.
Narrative Drafting: Create clear and concise draft narratives of reported events, following a standard narrative construction guide.
Follow-Up Queries: Formulate follow-up queries as necessary to gather additional information for case processing.
Regulatory Compliance and Reporting:
Ensure timely submission of expedited case reports to regulatory authorities.
Assist in the preparation of aggregate reports, ad hoc compilations, and other regulatory documents.
Maintain compliance with all applicable corporate, local, and global regulations for safety reporting.
Collaboration and Coordination:
Work closely with PV Management, Project Managers, and other team members to meet client project deadlines.
Support other PV staff to efficiently manage the workload and ensure timely reporting to regulatory authorities.
Develop expertise in the client’s products and therapeutic area, applying this knowledge to ensure accurate safety data reporting.
Assist in the reconciliation of serious adverse events (SAEs) between safety and clinical trial databases for ongoing clinical studies.
Skills and Experience:
Education: A BS degree in a life science discipline (e.g., Pharmacy, Nursing) is preferred.
Experience: A minimum of 5 years of relevant experience, including 3 years in drug safety.
Knowledge: Broad knowledge of domestic and international drug safety regulations and industry practices.
Coding Expertise: Strong working knowledge of MedDRA and WHODRUG coding dictionaries.
Regulatory Knowledge: Familiarity with FDA and international adverse event reporting regulations per ICH guidelines.
Medical Terminology: Solid understanding of medical terminology and adverse event reporting principles.
Attention to Detail: Strong attention to detail and quality-oriented approach to work.
Key Competencies:
Positive Attitude and Energy: Exhibits an upbeat attitude and energizes others.
Communication Skills: Able to articulate ideas and information clearly, motivating others to participate.
Innovative Thinking: Transforms creative ideas into actionable solutions that positively impact company performance.
Integrity: Demonstrates high moral and ethical behavior, maintaining credibility and professionalism in all actions.
Why EVERSANA?
At EVERSANA, we value diversity, equity, and inclusion in all aspects of our work. We are committed to creating an environment where all employees can thrive, contribute their unique perspectives, and help improve patient outcomes around the world. Joining EVERSANA means being part of a forward-thinking, collaborative, and inclusive team that cares deeply about the patients we serve and the impact we make globally.
#LI-REMOTE
EVERSANA is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.
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