Associate Manager, Pharmacovigilance

1 month ago


Florham Park, United States Clinical Resource Network (CRN) Full time

Our client is looking for a Associate Manager, Pharmacovigilance for a Hybrid position in the Livingston, NJ area.


Responsibilities:


  • Responsible for full oversight of individual case safety reports (ICSRs) and aggregate safety reports for company product portfolio.
  • Manage review of individual case safety reports to ensure timely processing of adverse event reporting.
  • Responsible for beginning to end ICSR case processing related to company sponsored trials, requiring collaboration with all clinical trials partners and participants.
  • Assist with review and preparation of aggregate safety reports (such as PADERs and PBRERs).
  • Manager preparation of PVA/SDEA documentation.
  • Reconciliation oversight with business partners, domestic and global teams.
  • Closely interact with PV service provider for vendor oversight, compliance monitoring and performance monitoring.
  • Responsible for research and creation of FAQs and Standard Response Letters to address inquiries from patients, HCPs and internal stakeholders.
  • Review scientific literature for the identification of reportable cases.
  • Inspection readiness maintenance responsibilities.
  • Serve as mentor to help develop junior staff on the PV team.


Required Qualifications:


  • MS Office proficiency.
  • Prior knowledge of PV databases (i.e. ARGUS and ArisG).
  • EDC clinical trial system experience (i.e. Medidata Rave, Veeva or ClinTrak).
  • Applicable degree in a scientific field (RPh, Pharm.D, RN preferred).
  • 4+ years of related Pharmacovigilance experience within a pharmaceutical or CRO environment.
  • Demonstrated knowledge of the drug development process, signal detection activities and regulatory processes.
  • Strong understanding of safety regulations, both domestic and global.
  • In depth knowledge of all applicable clinical, scientific and medical terminology (i.e. MedDRA coding).
  • Working knowledge of MedDRA and WHODrug.
  • FDA/EMA/ICH guideline knowledge.


Clinical Resource Network Distinction


CRN, a division of Solomon Page, offers a comprehensive benefits program for hourly employees. We pride ourselves on offering medical, dental, vision, 401(k), telehealth services, ESOP, and commuter benefits to our employees, including consultants - which sets us apart in the industries we serve.


About CRN


Founded in 2002, Clinical Resource Network (CRN), a division of Solomon Page, provides clinical research and talent solutions for pharmaceutical, biotech, and medical device companies. Focused on forming long-term relationships, services encompass contract staffing, project staffing, consultative services, and full-time placements. For more information, visit and connect with us on Facebook and LinkedIn.


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