1:00 PM - 2:00 PM
Senior Product Manager Interview
Sarah Jenkins
Pharmaceutical and biotech companies across the USA are expanding their pharmacovigilance teams, driving strong demand for drug safety associate remote jobs. With 451 open positions available, this opportunity lets professionals support patient well-being from anywhere in the country. Hiring managers nationwide are eager to fill these roles quickly.
Success in this position requires strong knowledge of adverse event case processing, MedDRA coding, and pharmacovigilance databases such as Argus or ArisG. Employers value analytical thinking, close attention to detail, and familiarity with FDA and ICH reporting standards. Clear communication and collaboration with regulatory affairs teams round out the skill set sought for most drug safety associate positions.
Remote work for this role typically involves managing cases through secure, cloud-based systems while coordinating with safety teams via video calls and shared platforms. Companies throughout the USA continue to embrace decentralized pharmacovigilance operations, reflecting a broader shift toward flexible staffing models. This trend has fueled a steady rise in drug safety associate vacancies as employers compete for experienced talent.
If you're ready to grow your career in pharmacovigilance, now is a great time to explore new opportunities. Global Work AI connects skilled professionals with employers looking to hire a drug safety associate for remote positions nationwide. Browse current openings and take the next step toward a rewarding career today.

MSD
Lead pharmacovigilance and clinical risk management for investigational and marketed products. Oversee safety data evaluation, aggregate clinical trial data analysis, and risk management activities. Collaborate with cross-functional teams to ensure alignment with global pharmacovigilance strategies.

Lilly
Support pharmacovigilance activities by analyzing safety data, identifying safety signals, and contributing to risk-benefit assessments. Oversee literature surveillance and coordinate signal review activities.

Lilly
Provide medical safety oversight for late-stage clinical studies, including reviewing individual and aggregate safety data. Lead safety surveillance, signal management, and benefit-risk assessments. Contribute to regulatory submissions and support interactions with health authorities.

Worldwide Clinical Trials
Manage clinical research activities at investigative sites, ensuring compliance with protocol and regulatory standards. Conduct monitoring visits, train site personnel, and support study start-up and closeout activities.

Biogen
Lead regulatory strategy for Class III medical device submissions, ensuring compliance with FDA and EU regulations. Manage a team of regulatory affairs staff, overseeing submission content and approval strategies.

Regeneron Pharmaceuticals
Oversee completion of Toxicology department goals with minimal supervision, directing junior specialists. Conduct study monitoring for outsourced non-GLP and GLP studies, ensuring compliance with protocols.

Worldwide Clinical Trials
Manage clinical research activities at investigative sites, ensuring compliance with protocol and regulatory standards. Conduct monitoring visits including Pre-Site Selection, Study Initiation, Interim Monitoring, and Closeout Visits.

Amgen
Serve as the safety leader for Obesity development programs, leading global safety strategy and pharmacovigilance activities. Partner with Clinical Development and Translational Medicine teams to inform key development decisions.

Jobgether
Provide medical safety leadership across clinical-stage investigational therapies, overseeing clinical safety activities throughout drug development. Conduct medical reviews of serious adverse events and evaluate safety cases, ensuring proper documentation.

Worldwide Clinical Trials
Manage clinical research activities at investigative sites, ensuring compliance with regulatory standards and protocol adherence. Conduct monitoring visits, train site personnel, and support study start-up and closeout activities.

Advocate Health
Conduct patient safety event investigations, including apparent cause analyses and chart reviews. Manage patient safety data, ensuring timely updates and coding for analysis.

Avalyn Pharma
Provide medical leadership and oversight of safety for inhaled antifibrotic investigational products. Review adverse event cases, perform safety assessments, and lead safety review meetings.

INDEGENE LIMITED
Manage end-to-end pharmacovigilance (PV) package preparation and documentation control. Perform quality reviews of safety cases and documentation, oversee PV mailbox operations, and maintain educational program documentation.

MiniMed
Provide technical and clinical information regarding product usage and performance related to patient safety. Collaborate with Research and Development, Risk Management, Quality, Regulatory, and Clinical teams. Evaluate safety signals and author safety assessments based on various data sources.

Lonza
Drive new business opportunities for Drug Product Services across the NAM region. Identify and develop strategic relationships within target accounts, analyze market trends, and inform go-to-market strategies.

Iovance Biotherapeutics
Lead the transition of regulatory information management from Veeva Vault RIM to Generis CARA, including scope, timeline, data migration, and validation. Partner with various departments to translate business needs into system requirements and deliver IT solutions.
EHS Insight
Manage customer onboarding to minimize time to value, lead customers through the onboarding process, and resolve issues. Respond to support tickets, clarify requests, and determine optimal solutions. Identify opportunities for additional modules and inform customers of new software features.

Otsuka Pharmaceutical Co., Ltd.
Manage the reporting of adverse event data in compliance with global regulations. Oversee internal submissions processes, track ICSR timelines, and ensure accuracy of regulatory submissions.

Liquidia
Oversee pharmacovigilance operations for clinical trials and marketed products, ensuring compliance and operational execution. Manage vendor oversight, aggregate report project management, and maintain the PV quality system.

Sumitomo Pharma America, Inc.
Lead cross-functional Safety Management Team meetings, providing safety guidance for key documents. Conduct signal detection and safety evaluations, ensuring compliance with safety governance processes.

UHS
The Medication Safety Coordinator is responsible for collecting, verifying, and documenting patients' medication histories. This role collaborates with patients, caregivers, pharmacies, and healthcare providers to prevent medication errors and improve patient safety.

Thermo Fisher Scientific
Oversee safety management services, ensuring compliance with SOPs, ICH guidelines, and regulatory requirements. Manage departmental operations, including budget oversight and resource utilization. Develop departmental SOPs and strategies to meet company goals.

Biogen
Manage global pharmacovigilance for investigational and marketed products, including safety data review and analysis. Lead safety strategic initiatives for clinical development programs and ensure timely completion of safety reports in compliance with regulations.

Parexel
Support monitoring and site management activities for client-sponsored studies, ensuring compliance with protocols and regulations. Conduct site visits, manage drug accountability, and oversee CRO partner activities.

Asahi Kasei
Lead and direct all product safety and pharmacovigilance activities, ensuring compliance with global regulations. Oversee safety surveillance for investigational and marketed products, manage vendor performance, and contribute to clinical development programs.

Celgard
Lead and direct all product safety and pharmacovigilance activities, ensuring compliance with global regulations. Oversee safety surveillance for investigational and marketed products, manage vendor performance, and ensure operational excellence.

Harrow, Inc.
Assess and process adverse event reports and Individual Case Safety Reports (ICSRs) in compliance with regulatory requirements. Engage with healthcare professionals to gather information on adverse events and support timely regulatory submissions.
Lifelancer
Lead Drug Safety Operations activities, ensuring timely and compliant collection, assessment, and reporting of safety information. Oversee pharmacovigilance operations including case processing, ICSR management, and regulatory submissions.

Pharmaron
Establish and lead U.S. pharmacovigilance operations, developing processes and capabilities. Manage pharmacovigilance projects, ensuring timelines, quality, and regulatory compliance. Serve as primary contact for U.S. clients, overseeing project discussions and operational challenges.

Thermo Fisher Scientific
Lead GPS Safety Data Management and Safety System Maintenance activities. Manage Oracle Argus Safety system configuration and administration, ensuring reliable drug safety case processing.

Revolution Medicines
Develop and implement global CMC regulatory strategies for clinical development and marketing authorizations. Prepare and maintain CMC sections for regulatory submissions, including IND, NDA, and MAA.

MapLight Therapeutics
Manage safety surveillance and signal detection activities, including periodic reviews of aggregate safety data and safety governance meetings. Develop signal assessment reports and collaborate with pharmacovigilance operations for medical reviews of individual case safety reports (ICSRs).

ModMed
Assist in day-to-day operations of the Patient Safety program, collaborating with various teams to review patient safety incidents. Manage Jira Cloud dashboards for data integrity and timely triage of tickets.

Worldwide Clinical Trials
Lead global pharmacovigilance projects and teams, ensuring compliance with regulations and quality standards. Provide strategic oversight of staff and project performance, addressing risks and issues.

Revolution Medicines
Represent regulatory science on cross-functional teams, providing regulatory advice on clinical development. Plan, prepare, and coordinate regulatory submissions while ensuring quality and adherence to timelines.

CG Oncology Inc
Lead global pharmacovigilance (PV) operations for clinical trials and post-marketing activities. Ensure compliance with FDA, EMA, ICH, GCP, and GVP standards. Oversee vendor management, case processing, safety data integrity, and aggregate reporting.

Alpha Staffing and Recruiting
Ensure compliance with DOT, OSHA, and FMCSA safety regulations. Develop and implement safety programs, conduct audits, and monitor safety requirements. Validate carrier certifications and licenses, perform credit checks, and manage the carrier onboarding process.

Pulmovant
Lead formulation and process development for inhaled dry powder products, ensuring manufacturability and compliance. Collaborate with cross-functional teams and external CDMOs to manage technical deliverables and resolve risks.

IGS Energy
Maintain OSHA recordkeeping, including logs and compliance documentation. Coordinate Safety Incident Management processes and oversee the Chemical Inventory Program. Conduct workplace inspections and hazard assessments, and collaborate with teams to design safety training programs.

mpathic
Oversee clinical quality for AI safety evaluations, data annotation, and labeling projects. Review annotations and AI model responses for clinical accuracy. Lead quality assurance and training for clinical experts and annotators. Identify safety risks and improve QA workflows.
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