Senior Analyst, Supplier Pharmacovigilance

Quallent is actively recruiting a Senior Analyst to support our Supplier Pharmacovigilance team in our Quality and Regulatory Compliance department. 

The Person | A detail-oriented professional with experience in pharmacovigilance and product quality. The ideal candidate will be skilled in managing adverse events and product complaint processes, collaborating with external partners, and ensuring compliance with Food and Drug Administration (FDA) and regulatory requirements. Experience with Contract Manufacturing Organizations (CMOs), safety agreements, and risk management is essential.

As a Senior Analyst you will:

Ensure any external sources of communication (e.g., FDA) are communicated to our Medical Information Contact Center Provider (MICCP) within the stipulated time frame to create Adverse Event (AE) and/or Product Complaint (PC) reports to distribute to the necessary CMO(s).

Responsible for the early identification and detection of potentially significant AEs/PCs and works with CMOs to ensure any reporting is completed to the FDA within the stipulated time frame as per regulatory requirements.

Ensure the CMO follows the responsibilities stipulated in the Pharmacovigilance Agreement (PVA) / Safety Data Exchange Agreement (SDEA) and Quality Agreement (QA).

Review and assess each investigation report / Health Hazard Assessment Report (HHAR) from the CMO for completeness, robustness and evaluation of drug safety information and make autonomous decision about acceptance of the case.

Coordinate with CMOs to close-out each case after internal acceptance of investigation report. If necessary, coordinate with the pharmacy to resume or reject dispensing of affected batch(es).

Work with the CMO to ensure Corrective and Preventive Actions (CAPAs) are effective to prevent recurrence of incidents/ observations.

Identify and monitor trends of reoccurring AEs, PCs and coordinate with CMO for identification and prevention to ensure patient health and safety is not compromised and to maintain quality control of products.

Maintain the internal AE/PC/Medical Inquiry (MI) tracker.

Work with CMOs, MICCP, pharmacies and any other necessary stakeholders, if required, for product recall activities.

Education & Experience | A Bachelor’s degree in Pharmacy, Chemistry, Biology or a related Health Science field or Pharmacy Technician certification is required. Experience in industry (Pharmaceutical, Biotechnology or Medical Device companies) or in practical health profession setting (Nursing, Pharmacy) is ideal. Knowledge of applicable USFDA requirements preferred but not required. Experience working in post-marketing drug safety surveillance and reporting preferred but not required.

Benefits | Quallent offers a highly competitive benefits package.