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Pharmacovigilance Aggregate Reporting Jobs (NOW HIRING)

AA2IT

Pharmacovigilance

North Wales, PA · On-site

Pharmacovigilance Safety Specialist Education: Bachelor's degree or Master's degree or Advance ... ICSR) and aggregate reporting. More focus is on the Individual Case Safety Report (ICSR)

Jobtailor

Director, Pharmacovigilance

Seattle, WA · On-site

$110 - $180/hr

Contribute to development and maintenance of SOPs and Pharmacovigilance System Master File (PSMF ... Familiarity with aggregate reporting and signal detection processes * Experience in oncology, cell ...

Umoja Biopharma

Director, Pharmacovigilance

$204K - $305K/yr

Coordinate with Clinical Development to drive internal cross-functional pharmacovigilance activities Aggregate Reporting & Regulatory Support * Lead or contribute to preparation of DSURs, PSURs ...

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How much do pharmacovigilance aggregate reporting jobs pay per hour?

As of Aug 26, 2026, the average hourly pay for pharmacovigilance aggregate reporting in the United States is $49.14, according to ZipRecruiter salary data. Most workers in this role earn between $38.46 and $55.53 per hour, depending on experience, location, and employer.

What is pharmacovigilance aggregate reporting?

Pharmacovigilance aggregate reporting refers to the process of compiling and analyzing safety data from multiple sources over a specific period to assess the overall benefit-risk profile of a pharmaceutical product. These reports, such as Periodic Safety Update Reports (PSURs) and Periodic Benefit-Risk Evaluation Reports (PBRERs), are submitted to regulatory authorities to ensure ongoing monitoring of drug safety. The goal is to identify new risks, evaluate changes in known risks, and determine if updates to product labeling or risk management plans are necessary. Aggregate reporting is a critical component in maintaining patient safety throughout a product's lifecycle.

What are the key skills and qualifications needed to thrive as a pharmacovigilance aggregate reporting specialist?

To excel in Pharmacovigilance Aggregate Reporting, you need a solid background in life sciences or pharmacy, strong analytical skills, and familiarity with regulatory requirements such as ICH guidelines. Experience with safety databases (like Argus or ARISg), proficiency in Microsoft Office Suite, and understanding of global pharmacovigilance regulations are highly valued. Exceptional attention to detail, organizational skills, and the ability to communicate complex safety data clearly set top performers apart. These competencies ensure accurate, compliant safety reports that are critical for patient safety and regulatory submissions.

What are some common challenges professionals face in pharmacovigilance aggregate reporting, and how can they be effectively managed?

Professionals in pharmacovigilance aggregate reporting often encounter challenges such as managing large volumes of safety data, meeting tight regulatory deadlines, and ensuring compliance with evolving international guidelines. Effective management involves developing strong project management skills, staying updated on regulatory requirements, and utilizing specialized safety databases and automation tools. Collaboration with cross-functional teams, such as clinical, regulatory, and medical affairs, is also essential to ensure data accuracy and timely report submission.

What is the difference between Pharmacovigilance Aggregate Reporting vs Pharmacovigilance Case Processing?

AspectPharmacovigilance Aggregate ReportingPharmacovigilance Case Processing
Primary FocusCompiling and analyzing safety data trends across populationsProcessing individual adverse event reports
Skills & CertificationsKnowledge of safety databases, regulatory guidelines, data analysisAttention to detail, case management, medical review
Work EnvironmentData analysis teams, regulatory submissionsCase intake, medical review teams
Industry UsageRegulatory reporting, safety surveillanceInitial case assessment, data entry

While both roles are essential in pharmacovigilance, aggregate reporting focuses on analyzing safety data trends for regulatory submissions, whereas case processing involves managing individual adverse event reports. Understanding these differences helps clarify career paths and job expectations in pharmacovigilance teams.

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Pharmacovigilance Aggregate Reporting jobs near you
Infographic showing various Pharmacovigilance Aggregate Reporting job openings in the United States as of August 2026, with employment types broken down into 1% As Needed, 84% Full Time, 12% Part Time, and 3% Contract. Highlights an 89% Physical, 4% Hybrid, and 7% Remote job distribution, with an average salary of $102,217 per year, or $49.1 per hour.

Scientist - Pharmacovigilance

Cambridge, MA • On-site

IntelliPro Group Inc.
Recruiting and Staffing Services • 201 - 500 employees
Learn more about IntelliPro Group Inc.external

$70.61/hr

Contractor

This job post has expired 1 day ago. Applications are no longer accepted.

Job description

Job Title: Scientist - Pharmacovigilance
Location: Hybrid - Cambridge, MA 02142
Duration: 09/21/2026 to 09/20/2027 with possible extension
Pay rate: $70.61/hr. on W2
Job Description:
The PV Aggregate Reports Scientist is part of the Safety Surveillance and Aggregate (SSA) Reports team and is responsible for managing the processes for all aggregate reports (PSURs, DSURs, PADERs, and local reports).
In this role, you will:
  • Serve as a subject matter expert on worldwide aggregate reporting safety requirements for the PV Scientist team, Safety, and cross-functional partners.
  • Respond to safety questions from internal and external stakeholders while reviewing and supporting the authoring of medical and scientific safety information.
  • Work closely with vendors, vendor oversight, and Quality Management teams to ensure high-quality standards across PV documents.
  • Support process improvement initiatives in collaboration with PV Sciences and cross-functional groups to develop, implement, and maintain compliant, efficient, and consistent global PV processes.

Key Responsibilities:
  • Aggregate Report Management: Lead and conduct all aspects of substantive projects, including the authoring and project management of PSURs, DSURs, PADERs, and local reports independently or collaboratively.
  • Subject Matter Expertise: Act as an expert on relevant safety requirements, company policies, and aggregate reporting knowledge; represent and articulate processes in cross-Safety and cross-functional forums.
  • Schedule & Regulatory Oversight: Support the Aggregate Reports Master Schedule (production, updates, stakeholder reviews), conduct worldwide legislation reviews for aggregate reporting, and provide impact assessments.
  • Health Authority Responses: Support authoring responses to safety inquiries from regulatory authorities alongside PV Scientists and key stakeholders.
  • Process Optimization: Drive process improvement initiatives to enhance consistency in aggregate reporting, signal management, clinical trial safety oversight, and ad hoc safety responses.
  • Implementation: Maintain existing procedures and support the rollout of new PV processes.

Essential Skills and Qualifications:
  • Data Interpretation & Communication: Ability to understand, interpret, analyze, and clearly present scientific and medical data verbally and in writing (including medical concepts and terminology).
  • Cross-Functional Collaboration: Proven track record of working collaboratively in a team environment across Safety, Clinical Development, Medical Affairs, Clinical Operations, Regulatory, and external colleagues.
  • Clinical Judgment: Ability to apply clinical judgment to interpret case information and guide staff on case data evaluation.
  • Regulatory & PV Knowledge: Familiarity with pharmacovigilance, drug development, clinical trial safety regulations, and post-marketing safety regulations (including case processing, expedited reporting, and safety databases).
  • Organization & Independence: Strong organizational skills with the ability to prioritize tasks independently with minimal supervision.
  • Technical Proficiency: Basic knowledge of standard software (Excel, PowerPoint, Word, Business Objects) and familiarity with common safety database systems.

Education & Experience Requirements:
  • Education: Bachelor's degree in biological or natural sciences required; Advanced degree (MSc, PhD, MPH, PharmD, etc.) preferred.
  • Experience: Minimum of 5 years of Pharmacovigilance experience, including direct experience in aggregate safety report writing and safety signal management.

About Us:
Founded in 2009, IntelliPro is a global leader in talent acquisition and HR solutions. Our commitment to delivering unparalleled service to clients, fostering employee growth, and building enduring partnerships sets us apart. We continue leading global talent solutions with a dynamic presence in over 160 countries, including the USA, China, Canada, Singapore, Japan, Philippines, UK, India, Netherlands, and the EU.
IntelliPro, a global leader connecting individuals with rewarding employment opportunities, is dedicated to understanding your career aspirations. As an Equal Opportunity Employer, IntelliPro values diversity and does not discriminate based on race, color, religion, sex, sexual orientation, gender identity, national origin, age, genetic information, disability, or any other legally protected group status. Moreover, our Inclusivity Commitment emphasizes embracing candidates of all abilities and ensures that our hiring and interview processes accommodate the needs of all applicants. Learn more about our commitment to diversity and inclusivity at https://intelliprogroup.com/.
Compensation: The pay offered to a successful candidate will be determined by various factors, including education, work experience, location, job responsibilities, certifications, and more. Additionally, IntelliPro provides a comprehensive benefits package, all subject to eligibility.

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