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Aggregate In Pharmacovigilance Jobs in Basking Ridge, NJ

AA2IT

Pharmacovigilance Technician

Rahway, NJ · Hybrid

$32.10/hr

Pharmacovigilance Technician Pay Rate: $32.10 Location: 126 E. Lincoln Avenue, Rahway, NJ 07065 ... • Aggregate adverse event report preparation, review, and submission In agreement with the ...

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Aggregate In Pharmacovigilance information

See Basking Ridge, NJ salary details

$12

$50

$88

How much do aggregate in pharmacovigilance jobs pay per hour?

As of Jul 28, 2026, the average hourly pay for aggregate in pharmacovigilance in Basking Ridge, NJ is $50.64, according to ZipRecruiter salary data. Most workers in this role earn between $39.62 and $57.21 per hour, depending on experience, location, and employer.

What are aggregate reports in pharmacovigilance?

In pharmacovigilance, aggregate reports are summaries of safety data collected from multiple individual case reports, providing an overview of adverse drug reactions and safety trends. Aggregate reporting is essential for identifying potential safety signals and is often required by regulatory agencies to monitor a drug's safety profile over time. Professionals in pharmacovigilance use statistical tools and follow guidelines like ICH E2E to prepare these reports for regulatory submission.

What are some common challenges faced by professionals working in aggregate reporting within pharmacovigilance?

Professionals involved in aggregate reporting in pharmacovigilance often encounter challenges such as managing large volumes of data from multiple sources, ensuring compliance with evolving global regulatory requirements, and meeting strict submission deadlines. Coordinating with cross-functional teams—such as clinical, regulatory, and safety departments—is essential for gathering accurate information and maintaining data consistency. Attention to detail and strong organizational skills are crucial to ensure that periodic safety update reports (PSURs), periodic benefit-risk evaluation reports (PBRERs), and other aggregate reports are comprehensive and error-free.

What are the key skills and qualifications needed to thrive as an Aggregate in Pharmacovigilance, and why are they important?

To thrive in an Aggregate role in Pharmacovigilance, you need a solid background in life sciences or pharmacy, strong analytical abilities, and experience with safety data analysis and regulatory reporting. Familiarity with pharmacovigilance databases (such as Argus or ArisG), signal detection tools, and an understanding of global regulatory guidelines (e.g., ICH, EMA, FDA) are typically required. Excellent attention to detail, organizational skills, and effective communication are essential soft skills for interpreting complex data and collaborating across teams. These competencies are crucial for ensuring accurate safety reporting, regulatory compliance, and the protection of patient health.

What are the career paths in pharmacovigilance?

Career paths in pharmacovigilance include roles such as PV associate, safety scientist, safety physician, and PV manager. Progression often involves gaining experience, developing expertise in regulatory requirements, and obtaining certifications like the Drug Safety Certification, leading to senior or leadership positions within the field.

What is the difference between Aggregate In Pharmacovigilance vs Pharmacovigilance Associate?

AspectAggregate In PharmacovigilancePharmacovigilance Associate
CredentialsTypically requires a degree in life sciences, pharmacy, or related field; certifications like PV training are commonSimilar educational background; often requires PV-specific training or certifications
Work EnvironmentFocuses on data analysis, signal detection, and reporting of safety data at a higher levelInvolves data entry, case processing, and supporting safety reports
Employer & Industry UsageUsed in pharmaceutical companies, CROs, and regulatory agencies for safety data analysisCommonly employed in similar settings for case management and data entry

In summary, Aggregate In Pharmacovigilance primarily handles data analysis and safety signal detection, requiring advanced skills in data interpretation. Pharmacovigilance Associates focus on case processing and data entry tasks. Both roles require relevant certifications and work within the same industry environment, but differ in scope and responsibilities.

What is the rule of 3 in pharmacovigilance?

In pharmacovigilance, the rule of 3 is a guideline used to assess the likelihood that an adverse event is related to a drug, suggesting that if an event occurs three times in a specific context, it warrants further investigation. It helps PV professionals prioritize signals and determine the need for additional safety analysis or reporting.
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Aggregate In Pharmacovigilance jobs near you
Compliance officer Pharmacovigilance/Clinical Development

Compliance officer Pharmacovigilance/Clinical Development

Stem Xpert

Whippany, NJ

$34/hr

Contractor

Posted 3 days ago

Job description

Company Description


.

Job Description

Role: GPV Compliance Officer

Duration: 1 year

Type: Pharmaceutical

Environment:

Business Casual

Billable Rate Range:

$34.00 per Hour


Minimum Requirements:

Master's degree or Doctoral degree in Pharmaceutical Science or Applied science preferred with minimum of 2 years' experience in Pharmacovigilance or Clinical Development required .

Bachelor's degree in nursing or applied science and at least 4 years' experience in Pharmacovigilance or Clinical Development considered.

Very good knowledge of Pharmacovigilance relevant regulatory obligations including reporting rules and timelines.

Experience and good performance using MS Office programs and in working with databases.

Strong customer orientation, creative and conceptual thinking required related to metrics, reports and case investigations.

Analytic thinking required to detect patterns in data and derive improvement measures.

\Strong attention to details and proven ability to work in international and multicultural teams required.

Excellent command of English language verbal and in written a must.

Applicant must meet ALL of these requirements.

Description:

As part of the GPV Compliance Officer role the candidate will develop expertise in the following activities:

Conducts root cause analysis (RCA) for late individual safety reports (single case handling for all CC and Pharma products)

Performs detailed RCA analysis for late single cases reviewing case information in the ARGUS system and the PV Monitor CAPA database

Conducts and documents thorough investigations

Provides root cause analysis using the QAC defined CAPA coding and guidelines

Communicates and approves corrective and preventative action(s) for non-compliance from multiple GPV external partners

Tracks implementation of corrective action related to RCAs developed during the compliance investigations

Compiles aggregate compliance data and participates in QAC generated metric reports

Contributes to further development and enhancement of GPV CAPA analytical processes and projects

Provides compliance analysis during inspections and audits as requested

Presents RCA results at weekly Global QAC teleconference

Supports development of business guidelines and SOPs

Ensures timely and quality entry of CAPA investigations in PVM

Works collaboratively with all QAC team members

Consistently demonstrates sound analytical and compliance principles

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About stem xpert

Sourced by ZipRecruiter

STEM Xpert, based in Ann Arbor, MI, US, is a leading company in the Science, Technology, Engineering, and Mathematics (STEM) education industry. Since their establishment, they have made an indelible mark by providing innovative services and products designed to enhance STEM learning. Their service portfolio includes comprehensive educational programs, customized learning modules and interactive STEM kits. Driven by a passion for nurturing young minds, the company's mission is to bring about an educational renaissance in the STEM field, making learning not just theoretical but practical and fun. One notable achievement for STEM Xpert has been its success in reaching a broad spectrum of learners, from school-age to adults, contributing significantly towards empowering the community's technological and scientific literacy.

Industry

Recruiting and staffing services

Company size

51 - 200 Employees

Headquarters location

Ann Arbor, MI, US

Year founded

2012

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