American Regent, Inc. · 4 days ago
Senior Manager, Pharmacovigilance
United States
Full-time
Hybrid
Senior Level, Lead/Staff
$165K/yr - $185K/yr
8+ years expAmerican Regent, Inc. is seeking a Senior Manager in Pharmacovigilance to oversee the collection and analysis of adverse events for marketed products and investigational compounds. The role involves managing operational activities, coordinating with various departments, and ensuring compliance with FDA regulations.
Health CareMedical
Responsibilities
Responsible for receiving and processing AEs reported to American Regent, Inc. from any internal or external source of any product sold or distributed by the company and its divisions
Responsible for managing all PV operational activities
Interact with Medical Monitors, Project Managers, CRAs, Project Coordinators, external clinical site investigators, nurses, pharmacists, patients, and outside corporate manufacturing partners/distributors in order to receive, follow-up, and report AEs according to company SOPs
Work with individuals in each division and across various departments (regulatory affairs, clinical R&D, medical affairs, and quality assurance) interfaced with the Pharmacovigilance process
Coordinate investigations with Quality Assurance (QA) Department
Provide input into SOPs, updates, and modifications to initiate appropriate changes
Provide input on end-user’s issue with safety database
Review of study safety tables and listings
Supervise intake of AEs, making certain all required elements of a safety report are captured and that FDA guidelines are followed
Daily distribution of adverse event reports to drug safety associates
Complies and distributes monthly reports
Oversees PV agreements (completion, revision, and resolution of partner issues, maintains spreadsheets/PV mailbox distribution list)
Oversees, tracks, and participates in reconciliation process concerning marketed products that are the subject of safety data exchange agreements
Answer company queries pertaining to safety database
Oversees completion of monthly ad-hoc literature searches and yearly contract renewals
Oversees quarterly process for copying of PV files for forwarding to headquarters liaise with cross functional teams such as: QA/RA/Medical Affairs/Clinical R&D for resolution of any PV-related issues
Participates in quality initiatives and any associated deviations as needed
Tracks case processing metrics for monthly reports to senior management/leadership
Prepare SAE narratives and collaborate with CROs/vendors for SAE reconciliation
Review and verify AE and concomitant medication coding via MedDRA and WHO Drug coding internally and with CROs/vendors
Identify safety signal and coordinate with Medical Directors as to their interpretation
Perform any other tasks/duties as assigned by management
Qualification
Required
Healthcare Professional, Pharm.D. or related Science Degree, BSN/RN/MSN required
Minimum of 8 years of experience in pharmacovigilance within pharmaceutical industry required
3+ years of experience in a supervisory or managerial role required
Knowledge of FDA Regulations for industry governing reporting of adverse drug experiences required
Knowledge/experiences with handling of adverse drug experiences
Excellent written and oral communication skills, strong analytical and problem-solving skills, strategic thinking, prudent decision making, proactive behavior, and the ability to collaborate effectively across multidisciplinary teams are essential
Strong technical aptitude with safety databases (e.g., Oracle ARGUS Safety Database) is required
Experience in authoring and reviewing internal documents such as Standard Operating Procedures, maintenance schedules and operating manuals
10% travel required for team meetings and potential audits
Preferred
Experience with internal and external audits is preferred
Benefits
Healthcare
Life insurance
Profit sharing
Paid time off
Matching 401k
A wide Range Of Other Benefits
Company
American Regent, Inc.
American Regent, Inc, a Daiichi Sankyo Group Company, develops, manufactures, and supplies high quality sterile injectables for healthcare providers, clinics and hospitals across the United States and Canada.
501-1000 employees
H1B Sponsorship
American Regent, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (6)
2024 (10)
2023 (4)
2022 (5)
2021 (8)
2020 (9)
Funding
Current Stage
Late StageLeadership Team
Paul Diolosa
President & CEO
Joseph Boyle
VP Finance / CFO
Recent News
GlobeNewswire
2026-01-09
thefly.com
2025-08-28
Company data provided by crunchbase