Our client is looking to fill the role of Manager, Pharmacovigilance. This will be a hybrid opportunity in the Livingston, NJ area.
Responsibilities:
- Support all PV related organizational activities including case processing, aggregate reports, PV vendor oversight, medical information inquiries and Safety Data Exchange Agreements.
- Manage review of individual case safety reports to ensure on time processing of adverse events, as well as monitor and track submissions to the appropriate health authorities.
- Responsible for review of aggregate safety reports to include PADERs, DSURS, PSURs/PBERS.
- Review and address medical information inquiries for HCPs, patients and internal stakeholders timely through FAQs and Standard Response Letters.
- Assist with preparation of Safety Data Exchange Agreements.
- Support creation and updating of departmental SOPs.
- Track scientific literature for potential adverse event reports related and submit for case processing timely.
- Responsible for providing PV input to clinical study related documents such as protocols, informed consent forms, case report forms, safety management plan, and protocol amendments.
- Contribute with review of SUSARs, SAEs, AESI related to clinical trials.
- Monitor regulatory authority guidance related to PV and assist with departmental implementation as required.
- Assist with authoring of CAPAs as required related to non-compliance.
- Responsible for supporting all GVP related audits and inspections, as well as any inspections related CAPA implementation.
Qualifications:
Education
- PharmD is required for this opportunity.
Experience (years/area):
- 5-7 years of experience in a related pharmacovigilance role within the pharmaceutical industry
- Seeking prior experience with post marketing surveillance activities and clinical trial case processing with a strong emphasis on post marketing exposure
- Prior experience in medical information or medical affairs to support medical information inquiries is required
- Experience with EDC clinical trial systems (e.g. Medidata Rave, ClinTrak, Veeva Vault)
- Experience working with safety databases such as ArisG or Argus preferred
- Sound knowledge of the Drug Development process, signal detection, and regulatory affairs
- Must possess strong working knowledge of MedDRA and WHO Drug
If you meet the required qualifications and are interested in this role, please apply today.
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 .
Opportunity Awaits.