Manager, Pharmacovigilance

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.