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Pioneer Data

Pharmacovigilance Scientist

Horsham, PA · On-site

... safety reports and other deliverables as applicable. Scheduled reports include PBRERs/PSURs, PADERs, Addendums to Clinical Overview, and PBRER/PSUR Addendum Reports. Non-scheduled reports include Ad ...

AstraZeneca

Associate Director, Safety Scientist

Boston, MA · On-site

$126K - $190K/yr

... PSUR, PBER, PADER, RMP, REMS, CSRs, and ad hoc requests in collaboration with GPS Medical Directors Authoring safety sections, in collaboration with team members, on regulatory responses, IBs/CCDS ...

Nova Pneuma, Inc.

Director, Regulatory Affairs

Fremont, CA

$192K - $253K/yr

Manage and prepare post-market filings and product safety reports (e.g., Annual Reports, DSUR, PSUR, REMS Annual Report, Supplements, Technical Documentation File lifecycle maintenance, responses to ...

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What are the key skills and qualifications needed to thrive as a PSUR (Periodic Safety Update Report) Safety Specialist, and why are they important?

To thrive as a PSUR Safety Specialist, you need expertise in pharmacovigilance, drug safety regulations, and medical writing, typically supported by a degree in pharmacy, life sciences, or a related field. Familiarity with safety databases (such as Argus or ARISg), regulatory guidelines (like ICH E2C), and submission systems is essential. Strong analytical skills, attention to detail, and effective communication set candidates apart in producing high-quality regulatory documents. These abilities are crucial to ensure accurate safety assessments, regulatory compliance, and patient safety in the pharmaceutical industry.

What are the main challenges faced by PSUR Safety professionals in managing periodic safety update reports?

One of the main challenges for PSUR Safety professionals is ensuring timely and accurate collection of safety data from multiple sources, such as clinical trials and post-marketing surveillance, which must then be synthesized into comprehensive reports. Coordinating with cross-functional teams—including regulatory affairs, medical writing, and pharmacovigilance—is essential but can be complex due to differing priorities and timelines. Additionally, keeping up with evolving global regulatory requirements and ensuring that all submissions are compliant adds another layer of complexity. Successful professionals in this role are highly organized, detail-oriented, and proactive communicators.

What is a PSUR Safety professional?

A PSUR (Periodic Safety Update Report) Safety professional is responsible for compiling, analyzing, and submitting periodic safety reports regarding pharmaceutical products to regulatory authorities. They ensure that the latest safety data is reviewed and that any new risks or benefits are clearly communicated to ensure ongoing product safety. Their work helps companies stay compliant with pharmacovigilance regulations and safeguards public health by identifying and managing potential risks associated with medicinal products.

What is the difference between Psur Safety vs Psur Safety?

AspectPsur SafetyPsur Safety
CertificationsOSHA 30-Hour, HAZWOPEROSHA 30-Hour, HAZWOPER
Work EnvironmentIndustrial sites, chemical plantsIndustrial sites, chemical plants
Employer & Industry UsageOil & gas, manufacturingOil & gas, manufacturing
Common Search & ComparisonSafety roles in industrial settingsSafety roles in industrial settings

Both Psur Safety and Psur Safety involve safety responsibilities in industrial environments, often requiring similar certifications and working in comparable settings. The key difference lies in specific job functions or employer terminology, but generally, they refer to safety roles focused on ensuring workplace safety in industrial industries.

Infographic showing various Psur Safety job openings in the United States as of May 2026, with employment types broken down into 5% As Needed, 90% Part Time, and 5% Temporary. Highlights an 99% Physical, and 1% Remote job distribution.
Senior Manager, Drug Safety

Senior Manager, Drug Safety

Supernus Pharmaceuticals, Inc.

Rockville, MD • On-site

Full-time

Medical, Dental, Vision, Life, Retirement, PTO

Posted 29 days ago

Job description

Supernus Pharmaceuticals is an award-winning biopharmaceutical company with more than 30 years of experience in developing and commercializing products that treat central nervous system (CNS) diseases. At Supernus, we develop innovative products that help treat neurological and psychiatric conditions. At Supernus, we develop innovative products that help treat neurological and psychiatric conditions. We currently have 8 products in the market that are making a real impact on patient outcomes.
Job Summary:
The Senior Manager of Drug Safety will support drug safety and pharmacovigilance operations to ensure the consistency and accuracy of adverse event reporting in clinical studies including initial safety review of adverse events and medical review of clinical data, interaction with drug safety vendors, review of source documents, and preparation of documents for submission to regulatory authorities.
Essential Duties & Responsibilities:
  • Participate in the operational aspects of adverse event reporting for all investigational products.
  • Ensure consistency in the evaluation and assessment of adverse event reports and source documentation for completeness, accuracy and legibility.
  • Ensure accuracy of MedDRA coding of adverse events' terms, medical history, and WHO Drug coding of concomitant medications.
  • Support the clinical research team in the preparation/review of safety reports/data; e.g., Annual Reports, cumulative SAE reports, safety database reports, clinical study reports, MedWatch Reports, Tables/Listings/Figures, and other reports as deemed necessary.
  • Participate in SAE Reconciliation activities.
  • Supports the timely safety review of adverse events to determine seriousness, expectedness, reporter's causality, and overall event resolution.
  • Perform review of SAEs and provide causality assessment in collaboration with the drug safety physician/medical monitor.
  • Provide oversight of end-to-end case processing and reviews.
  • Interact on a regular basis with contract drug safety vendors and internal departments as applicable (i.e. data management, medical affairs, biostatistics, clinical operations etc.) to resolve safety-related issues.
  • Review safety data output for accuracy and completeness prior to submission to internal and external sources.
  • Maintain current knowledge of all applicable drug safety guidelines and regulations (FDA) and apply to safety tasks.
  • Assists in preparation of safety documents for submission to regulatory authorities; in collaboration with the Regulatory Affairs Department.
  • Author/Review clinical documents as applicable e.g. protocol, study plans etc.
  • Ensure compliance with clinical protocol safety objectives, policies, processes, and procedures.
  • Maintain knowledge of relevant disease and therapeutic areas for marketed drugs and drugs in development.
  • Supports the Medical Affairs on adverse events seen with the use of marketed Products.
  • Perform other safety/pharmacovigilance operations-related tasks as necessary.
  • Knowledge and Experience with commercial products pharmacovigilance
  • Author/Review post-marketing safety reports (PSUR, PADER, PBRER etc)

Supervisory Responsibilities:
  • N/A.

Knowledge & Other Qualifications:
  • Degree in medical field (RN, PharmD or MD preferred), or significant experience in this line of work and a Master's Degree.
  • Minimum of 4 years of relevant work experience.
  • Knowledge of medical and therapeutic terminology.
  • Experience in medical monitoring and medical review
  • Experience in Standard Operating Procedures authorship.
  • Experience in safety database(s).
  • Working knowledge of ICH guidelines and other worldwide safety regulations.
  • Demonstrated working knowledge of FDA regulations relevant to Patient Safety and adverse event reporting, including periodic safety reporting.
  • Working knowledge of the principles and concepts associated with Patient Safety case-handling process, including regulatory reporting requirements, policies, processes and procedures.

Other Characteristics:
  • Ability to work independently and as part of a team and maintain high ethical standards of integrity and quality.
  • Ability of having an innovative and dynamic approach to work.
  • A self-starter able to work independently but comfortable working in a team environment.
  • Ability to consistently exhibit Supernus Values in interactions with employees at all levels of the organization, vendors, customers and others.
  • Capable of performing other duties as assigned by Management.
  • Authorized to legally work in the United States without visa sponsorship.

Physical Requirements/Work Environment/Travel Requirements:
  • Sedentary work. Exerting up to 10 pounds of force occasionally and/or carrying objects. Sedentary work involves sitting most of the time.
  • The worker is required to have close visual acuity to perform an activity such as: preparing and analyzing data and figures; transcribing; viewing a computer screen, iPad, or other electronic device; and extensive reading.
  • The worker is not substantially exposed to adverse environmental conditions.

Compensation:
At Supernus, we offer a competitive compensation package that reflects your experiences and contributions. The expected salary range for fully qualified candidates applying for this role is $130,000 to $155,000. This range is what the Company reasonably expects to offer for the position and is not reflective of the full compensation scale of the role. This range may be modified in the future. An individual's salary within the range is based on multiple factors, which may include and are not limited to education, relevant experience, knowledge, length of industry experience and organizational needs.
You also will be able to participate in a competitive benefits package, including but not limited to: health, dental, vision, paid time off, 401k company match, company paid life insurance and health and wellness benefits. The total compensation package for this position also includes other compensation elements such as stock equity awards, employee stock purchase programs and participation in our Company's discretionary annual bonus program.
Supernus Pharmaceuticals is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, national origin, disability, protected veteran status, age or any other characteristic protected by law.
Equal Opportunity Employer
This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.

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