1

Psur Safety Jobs (NOW HIRING)

Director, Safety Scientist

Boston, MA · On-site

$175K - $263K/yr

Responsible for project managing and authoring of safety documents including PSUR, PBER, PADER, RMP, REMS, CSRs, and ad hoc requests in collaboration safety physicians. * Responsible for authoring ...

Director, Safety Scientist

Boston, MA · On-site

$175K - $263K/yr

... PSUR, PBER, PADER, RMP, REMS, CSRs, and ad hoc requests in collaboration safety physicians. Responsible for authoring safety section in collaboration with team members on regulatory responses, IBs ...

Director, Safety Scientist

Boston, MA · On-site

$175K - $263K/yr

Responsible for project managing and authoring of safety documents including PSUR, PBER, PADER, RMP, REMS, CSRs, and ad hoc requests in collaboration safety physicians. * Responsible for authoring ...

Drug Safety Physician

Princeton, NJ · On-site

$150K - $250K/yr

Provide medical safety input and participate in safety surveillance activities (e.g ... Experience with preparation of aggregate reports (e.g., DSUR, PSUR/PBRER, PADER) * Experience in ...

Drug Safety Physician

Princeton, NJ · On-site

$150K - $250K/yr

Provide medical safety input and participate in safety surveillance activities (e.g ... Experience with preparation of aggregate reports (e.g., DSUR, PSUR/PBRER, PADER) * Experience in ...

Drug Safety Physician

Princeton, NJ · On-site

$150K - $250K/yr

Provide medical safety input and participate in safety surveillance activities (e.g ... Experience with preparation of aggregate reports (e.g., DSUR, PSUR/PBRER, PADER) * Experience in ...

... PSUR, etc.) and safety-related health authority requests in accordance with regulatory requirements * Participate in multidisciplinary teams at Neurocrine involving R & D project teams, clinical ...

next page

Showing results 1-20

Psur Safety information

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.
Sr. Director, Statistical Programming Safety

Sr. Director, Statistical Programming Safety

Penfield Search Partners

Foster City, CA • Hybrid

$226K - $292K/yr

Full-time

Posted 3 days ago


Job description

Contact: Lauren Scutero -
This is a permanent, hybrid position in Foster City, CA with two days (Monday, Friday) as optional work from home with core collaboration days in the office: Tues, Wed, Thurs. Fully home-based work is not available for this role.
Job Description Position Summary
Provides strategic, operational, and hands on (player coach) leadership for compound level safety statistical programming and aggregate safety reporting deliverables, including DSUR, PSUR/PBRER, Risk Management Plan (RMP), IBRSI, and support for broader safety surveillance and safety analytics. Leads teams and oversees vendors to ensure timely, high quality, and inspection ready delivery while driving modernization through AI enabled and automated programming approaches.
Key Responsibilities

  • Lead end to end programming strategy and execution for compound level aggregate safety reporting deliverables (DSUR, PSUR/PBRER, RMP, IBRSI).
  • Provide strategic oversight of roles, responsibilities, and build steps for aggregate safety programming delivery.
  • Serve as escalation point for complex pooled/cumulative safety analyses and urgent ad hoc safety requests.
  • Maintain hands on engagement to ensure technical correctness, reproducibility, and delivery reliability for critical outputs.
  • Ensure consistent processes, folder structures, and operational readiness for safety programming deliverables.
  • Own and continuously improve quality management practices, including definition and monitoring of KPIs.
  • Provide vendor/FSP oversight and governance, ensuring training readiness, documented expectations, and appropriate QC.
  • Lead, mentor, and develop Safety Statistical Programming staff; oversee less experienced colleagues and contribute to development of standards, tools, and templates.
  • Drive adoption of AI enabled and automated programming approaches to improve efficiency, consistency, and quality.


Capabilities & Requirements

  • Excellent written and verbal communication; strong influencing and negotiation skills.
  • Deep knowledge of drug development, regulatory expectations, and industry standards for safety programming and reporting.
  • Proven ability to lead people leaders, delegate effectively, coach performance, and support career development.
  • Strong judgment and problem solving skills in complex situations; ability to prioritize critical issues.
  • Demonstrated ability to work cross functionally and influence decision making.
  • Education & Experience
  • Bachelor’s degree or higher in Biostatistics, Computer Science, or related field with 12+ years of relevant industry experience.
  • 6+ years of leadership or cross functional project management experience, including managing project teams.
  • Significant line management experience with a proven record of hiring and developing high performing talent.
  • Extensive experience with SAS®; experience with R and/or Python preferred.
  • Demonstrated leadership in change management and standards adoption.


The salary range for this position is: $226,185.00 - $292,710.00.