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 https://www.solomonpage.com/crn and connect with us on Facebook and LinkedIn.
Opportunity Awaits.
