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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 Sep 7, 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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Cities with the most Pharmacovigilance Aggregate Reporting job openings:

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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, 11% Part Time, 1% Temporary, 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.

Pharmacovigilance

AA2IT

North Wales, PA • On-site

Other

Re-posted yesterday

Job description

Pharmacovigilance Safety Specialist

Education: Bachelor's degree or Master's degree or Advance level degree in a life science/healthcare/pharmaceutical related field.

Required: Candidate is required to have at least 2 years of pharmacovigilance safety experience or related areas such as Clinical Risk Management, Clinical or Regulatory preferred. Strong knowledge base of pharmacovigilance principles with close attention to detail and ability to be flexible in order to meet daily competing priorities of the business. Ability to independently contribute effectively to group projects, handle individual tasks, and take initiative when necessary. Veeva Vault experience preferred.

Software: MS office suite. Veeva Vault is preferred.

Personality: Detail Oriented. Able to work independently. Team Player. Excellent written and verbal communication skills.

Note: 1 year assignment. Hybrid assignment (2 days/week onsite). Work Location: Upper Gwynedd, PA.

Documentation and training role. Writing SOP's - we are responsible for maintaining Individual Case Safety Report (ICSR) and aggregate reporting. More focus is on the Individual Case Safety Report (ICSR). Familiarity with any Learning management system. Experience with My learning system is a plus. Need someone who can deliver and create trainings. Experience with safety database. Experience with VEEVA Vault is a plus.

Responsibilities:

We are looking for (2) Contractors to support PV Operations and Global Process Enablement in Documentation and Training and PV Quality and Compliance with responsibilities to include:

  • Documentation, training, and global standards team within Client in need of a supportive and highly motivated individual within their team that will assist in developing and maintaining documents outlining the processes to ensure high quality individual case and aggregate safety reporting in accordance with pharmacovigilance (PV) policy and regulations.
  • Assist in the management and maintenance of PV-controlled documents (e.g. Global Safety Database User Manual, Standard Operating Procedures, and training material).
  • Assist in the authoring, reviewing and implementation of new PV-controlled SOPs and supportive documents.
  • Assist in reviewing, creating, and delivering trainings.
  • Process incoming communications from internal and external sources and initiate appropriate course of action and/or response.
  • Perform quality review of expedited and periodic reports to ensure adherence to global case processing standards and regulatory requirements.
  • Monitor group mailboxes utilized for the centralization of process/subject specific inquiries.

Comments/Special Instructions: Documentation and training role. Writing SOP's-we are responsible for maintaining Individual Case Safety Report (ICSR) and aggregate reporting. More focus of Individual Case Safety Report (ICSR). Familiarity with LMS-My learning is a plus. Someone who can deliver and create trainings. Experience with safety database. Experience with VEEVA Vault is a plus.

If interested, kindly send updated copy of resume with following answers:

  • Which year you graduated your Bachelor's degree or Master's degree or Advance level degree and in which Discipline
  • How many years of exp in pharmacovigilance safety or related areas such as Clinical Risk Management, Clinical or Regulatory
  • How many years of exp in Writing SOP's-& maintaining Individual Case Safety Report (ICSR)and aggregate reporting.
  • How far you live from 351 North Sumneytown Pike, North Wales, PA and how will you commute daily
  • Giving Exclusive right to represent to our client for req ID: 35411

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