Associate Director - Postmarketing PV Case Management

4 days ago

🇺🇸 United States – Remote

🏄 California – Remote

Although this job is listed in California, this company may be open to hiring remote in other states.

🌲 North Carolina – Remote

Although this job is listed in North Carolina, this company may be open to hiring remote in other states.

+1 more states

🏄 California – Remote 🌲 North Carolina – Remote 🍂 Massachusetts – Remote

💵 $163k - $185k / year

⏰ Full Time

🟠 Senior

🎡 Marketing

Apply Now

Receive Emails with Similar Jobs

Foundation Finance Company LLC

WebsiteLinkedInAll Job Openings

Home Improvement Financing • Consumer financing • Installment loans • Revolving credit • Prime lending

51 - 200 employees

Description

• The Associate Global PV Case Management Director plays a key role in management and oversight of end-to-end case safety management activities. • This position strategizes and implements plans to ensure compliance with global regulations and guidelines. • This role is critical in ensuring that commercial operational aspects of pharmacovigilance activities are managed with rigorous global standards. • Evaluate, strategize, and execute process changes in response to regulatory updates. • Oversee day-to-day quality and compliance for vendor staff supporting adverse effect processing. • Provide strategic guidance to ensure compliance with global regulations. • Act as the main point of contact and functional manager regarding PM case handling. • Develop, facilitate, and provide training and training materials for AE, PC, and/or SRS collection. • Conduct root cause analysis of inspection or audit findings. • Initiate and lead the development and implementation of new or revised SOPs. • Oversee and resolve the PM reconciliation process.

Requirements

• Bachelor’s degree in nursing, chemistry, biology, or a related field • 12+ years of experience in pharmacovigilance in end-to-end case processing of ICSRs with a bachelor's degree or 10+ years with a master's degree or 7+ years with a PhD/PharmD/MD/DO/or international equivalent • Strong written and verbal communication skills • End-to-end case processing, including data entry, QC, medical review, and regulatory submissions • Project management skills and ability to organize and deliver large, complex projects independently • Working knowledge of drug development processes and activities • Strong analytical thinking to diagnose common situations • Ability to work effectively across functions • Working knowledge of MedDRA coding • Working knowledge of global regulations, guidelines and industry best practices for end-to-end case management for devices, biologics, and drug products

Benefits

• Medical / dental / vision / prescription coverage • Employee wellness resources • Savings plans (401k and ESPP) • Paid time off & paid parental leave benefits • Disability benefits • Short-term and long-term incentive programs