Clearing Pharmacovigilance Backlogs in the Pharmaceutical Industry

Pharmaceutical Staffing plays a critical role in protecting patient safety after drug approval. Because post-market surveillance relies on timely adverse event processing, staffing gaps create serious compliance and reputational risk. Pulivarthi Group partnered with a growing pharmaceutical manufacturer to eliminate pharmacovigilance backlogs, stabilize safety operations, and restore regulatory confidence.

Post-Market Risks Caused by Pharmaceutical Staffing Gaps

The company supported multiple commercial products across oncology and immunology. Although sales increased, safety infrastructure failed to scale. Consequently, adverse event case queues grew. Meanwhile, periodic safety update reports fell behind schedule. Leadership faced heightened concern as regulatory scrutiny intensified.

An internal review identified several high-risk issues:

• Insufficient case processing specialists for adverse event intake.
• Shortages of medical reviewers for serious and expedited cases.
• Delayed MedDRA coding and case reconciliation.
• Backlogs in literature surveillance and signal detection.
• Burnout among senior pharmacovigilance staff.

Guidance from the FDA Office of Surveillance and Epidemiology emphasizes timely case processing and signal management. Therefore, Pharmaceutical Staffing must scale rapidly to protect compliance and patient safety.

Pulivarthi Group’s Pharmaceutical Staffing Strategy for Pharmacovigilance

Pulivarthi Group designed a safety-focused staffing strategy that balanced speed, quality, and regulatory rigor. Because pharmacovigilance workflows depend on accuracy, the approach emphasized role specialization and workload balance. Furthermore, the plan delivered immediate backlog relief while strengthening long-term safety capacity.

Deploying Case Processing Specialists

Pulivarthi Group sourced pharmacovigilance professionals with hands-on experience in adverse event intake and case management. Each specialist demonstrated familiarity with ICSR workflows and safety databases. As a result, case throughput increased quickly.

Strengthening Medical Review Capacity

Medical review bottlenecks delayed serious case assessments. Therefore, Pulivarthi Group added safety physicians and clinical reviewers experienced in oncology and immunology products. Consequently, expedited cases moved through review faster.

Accelerating Coding and Data Quality Functions

Accurate coding supports signal detection. Pulivarthi Group introduced MedDRA coders and data quality specialists. Because these roles focused exclusively on classification accuracy, reconciliation errors declined.

Supporting Signal Detection and Literature Surveillance

Signal management required consistent oversight. Pulivarthi Group staffed epidemiologists and safety scientists aligned with ICH guidance (ICH Safety Guidelines). Therefore, the organization regained proactive risk identification capability.

Process Improvements Enabled by Pharmaceutical Staffing

Once staffing stabilized, pharmacovigilance workflows improved across all safety functions. Because the organization reduced manual strain, quality and consistency improved simultaneously.

Reducing Adverse Event Case Backlogs

Case queues declined rapidly as new staff joined. Consequently, processing timelines returned to regulatory expectations.

Improving Regulatory Reporting Timeliness

Expedited reports previously missed deadlines. With additional staffing, submissions aligned with regulatory timelines. Therefore, compliance risk dropped.

Balancing Safety Workloads to Prevent Burnout

Senior staff previously covered multiple roles. After redistribution, workloads stabilized. As a result, morale improved and attrition slowed.

Strengthening Inspection Readiness

Auditable documentation improved. Because staffing coverage increased, internal audits closed findings faster. Furthermore, leadership felt prepared for regulatory inspections.

Measured Results from Pharmaceutical Staffing Interventions

The pharmacovigilance staffing initiative delivered measurable improvements across safety operations and compliance posture.

• Cleared 92% of adverse event backlog within 90 days.
• Restored on-time submission for expedited safety reports.
• Reduced case processing cycle time by 46%.
• Improved data quality metrics across safety databases.
• Lowered pharmacovigilance staff turnover by 34%.
• Strengthened inspection readiness for global regulators.

Patient safety oversight stabilized. Regulatory exposure decreased. Internal teams regained control over safety operations.

Client Testimonials

“Our safety backlog posed serious risk. Pulivarthi Group solved it faster than we thought possible.”

— Dr. Rachel Monroe, Head of Pharmacovigilance

“Their staffing expertise restored our compliance posture. Regulators noticed the improvement.”

— Steven Patel, Director of Regulatory Compliance

“Burnout dropped once workloads balanced. Our safety team finally stabilized.”

— Laura Kim, Safety Operations Manager

“They understood pharmacovigilance deeply. That made execution seamless.”

— Michael O’Brien, Chief Medical Officer

Why Pulivarthi Group Excels in Pharmaceutical Staffing

Pulivarthi Group understands that post-market safety demands precision and speed. Pharmaceutical Staffing must protect patients, regulators, and brand integrity. Therefore, the team focuses on specialized pharmacovigilance talent, rapid deployment, and sustainable workload design. This approach ensures pharmaceutical companies maintain safety excellence while scaling commercial success.