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American Regent, Inc. · 14 hours ago

Pharmacovigilance Manager, Aggregate & Trend Reports

United States

Full-time

Hybrid

Senior Level

$135K/yr - $150K/yr

5+ years exp

American Regent, Inc. is seeking a Pharmacovigilance Manager to lead aggregate, trend, and signal detection reporting for human and veterinary products. The role involves compiling safety reports, coordinating with various departments, and ensuring compliance with regulatory guidelines.

Health CareMedical

H1B Sponsor Likely

Responsibilities

Generate PV trending data relating to both human and veterinary products

Complete routine queries of the Argus, Argus Insight, RxLogix and PV Works databases at American Regent, Inc

Lead work with cross-functional teams in improving processes, and support safety database upgrades, within aggregate reporting and safety analyses

Prepare PV data for Quarterly and Annual Periodic Adverse Drug Experience Reports (PADERs) and aggregate safety reports following regulatory guidelines and SOPs

Act as the RxLogix system business owner oversees setup, user access, coordinate with vendor any maintenance, upgrades and issue resolutions for PV Signal Detection

Prepare veterinary PV data for Yearly and 6-month Periodic Drug Experience Reports following regulatory guidelines and SOPs

Under the supervision of the department head or designee, coordinate the quarterly Data Safety Review Board (DSRB) meetings, preparation, distribution and filing of DSRB meetings/ ad hoc safety meetings. agenda, ad hoc safety meetings, minutes and archive of meeting agenda and reports

Work with individuals in each division and across various departments (Regulatory, Clinical R&D, Medical Affairs, Legal, Quantitative Sciences, and Quality Affairs) interface with the Pharmacovigilance process

This individual will maintain current knowledge of standard operating procedures (SOPs) and guidance documents including Worldwide/Health regulations

Maintain and update safety surveillance watchlist on a regular basis to ensure they remain current and compliant with internal procedures and regulatory requirements

Assist in the development and maintenance of Department SOPs and procedures

Perform any other tasks/duties as assigned by management

Qualification

PharmacovigilanceAggregate ReportingSignal DetectionSafety DatabasesMicrosoft WordMicrosoft ExcelTechnical WritingVerbal CommunicationProject Management

Required

Masters in Life Sciences, Biology, Biotech, Microbiology Degree or RN required

Minimum of 5 years' experience in Pharmacovigilance including the preparation of PADERS and knowledge of signaling/trending analysis; strong clinical background required

Ability to assess adverse drug reactions (ADRs) and interpret data

Excellent technical/medical writing and verbal communication skills; detailed knowledge of Microsoft Word and Microsoft Excel; ability to work independently as well as in a team environment

Able to manage and accomplish multiple priorities simultaneously

Able to lead/manage projects and work efficiently with both internal/external stakeholders as assigned by the supervisor

Preferred

PharmD or PhD a plus

Skills with safety databases (Argus, Argus Insight) is a plus

Knowledge of Worldwide/Health Authority regulations for pharmaceutical industry governing the reporting of adverse drug experiences/events in the post-marketing (spontaneous, literature, study) and IND environment preferred

10% travel maybe required for team meetings and potential audits

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.

Founded in 1967

Shirley, New York, USA

501-1000 employees

http://www.americanregent.com/

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)