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Pharmacovigilance Associate United States Jobs

3 Job Offers

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Associate Director, Pharmacovigilance Scientist
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Lead global pharmacovigilance and safety surveillance for assigned products in this Waltham-based role. Utilize your 10+ years of PV experience in signal management, benefit-risk assessment, and aggregate reporting. Enjoy comprehensive benefits, flexible time off, and a collaborative, cross-funct...
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United States , Waltham
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160000.00 - 200000.00 USD / Year
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Kailera Therapeutics
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Until further notice
Associate Director, Integrated Pharmacovigilance Operations
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Join Kailera's growing Pharmacovigilance team as an Associate Director. You will oversee global PV operations, ensuring compliance with FDA, EMA, and ICH guidelines. This role, based in Waltham, MA or San Diego, CA, offers comprehensive benefits, bonus opportunities, and equity. Utilize your 10+ ...
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United States , Waltham, Massachusetts; San Diego, California
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160000.00 - 200000.00 USD / Year
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Kailera Therapeutics
Expiration Date
Until further notice
Associate Director, Pharmacovigilance Planning and Innovations
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Lead strategic pharmacovigilance planning and drive innovation in this key Associate Director role. You will manage global PV projects, optimize processes, and integrate new technologies from concept to adoption. The position requires 10+ years in pharmacovigilance and strong project management s...
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Location
United States , Waltham
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Salary
160000.00 - 200000.00 USD / Year
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Kailera Therapeutics
Expiration Date
Until further notice
Explore a critical and growing career path with Pharmacovigilance Associate jobs, a cornerstone role in the global healthcare and pharmaceutical industry. Pharmacovigilance (PV) is the science dedicated to monitoring the safety of medicines, and Associates are the essential professionals who ensure patient safety by managing and analyzing data on adverse effects. This profession sits at the intersection of science, regulation, and patient care, offering a stable and impactful career for detail-oriented individuals. Professionals in these roles are primarily responsible for the end-to-end management of Individual Case Safety Reports (ICSRs). This involves the meticulous collection, data entry, assessment, and reporting of adverse event information from various sources like healthcare professionals, patients, and clinical trials. A typical day includes triaging incoming safety data, coding medical terms using standardized dictionaries like MedDRA and WHO Drug, verifying case completeness, and ensuring timely submission to health authorities and clients in full compliance with global regulations such as those from the FDA and EMA. Beyond case processing, common responsibilities often include drafting follow-up queries for additional information, contributing to aggregate safety reports like Periodic Safety Update Reports (PSURs), assisting with signal detection activities, and handling product quality complaints. They serve as a vital link, frequently collaborating with medical, regulatory, and quality assurance departments. To excel in Pharmacovigilance Associate jobs, a strong educational foundation in life sciences is essential. This typically means a bachelor’s or master’s degree in pharmacy, nursing, biology, biochemistry, or a related biomedical field. The role demands an exceptional eye for detail and accuracy, as working with sensitive patient data and regulatory documents leaves no room for error. Strong analytical and problem-solving skills are needed to assess complex medical information. Proficiency in written and verbal English is crucial for clear communication in reports and cross-functional collaboration, often in an international setting. Familiarity with major safety databases (e.g., ARGUS, ARISg) and Microsoft Office is a standard technical requirement. Equally important are soft skills like effective time management, the ability to prioritize tasks in a deadline-driven environment, and a steadfast commitment to ethical standards and patient safety. For those seeking a meaningful career that protects public health, Pharmacovigilance Associate jobs offer a dynamic entry point into the vital world of drug safety. It is a profession built on continuous learning, precision, and the profound satisfaction of contributing directly to the well-being of patients worldwide.

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