What are the responsibilities and job description for the Manager, Pharmacovigilance position at Clinical Resource Network (CRN)?
Our client is looking to fill the role of Manager, Pharmacovigilance. This will be a hybrid opportunity in the Livingston, NJ area.
- $140-$150k
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 https://www.solomonpage.com/crn and connect with us on Facebook and LinkedIn.
Opportunity Awaits.
Salary : $140,000 - $150,000
