IND123

The Associate Director/ Director, Drug Safety (Title is comensurate with experience) will oversee and implement operations of Pharmacovigilance in North America and communicate relevant information internally and with other members of SUN and its affiliates, including stakeholders as required. The Director will be responsible for ensuring ADE training and/or communication of handling ADEs for non-Drug Safety personnel and review market research surveys received from a pharmacovigilance perspective.

Responsibilities include the following

FDA, Health Canada and Internal Audit Inspections:

• Ensure audit preparedness and manage regulatory and internal inspections
• Draft any corrective action/preventative action plans(CAPA) as necessary

Compliance Monitoring:

• Ensure compliance to PV SOPs implemented in North America and generate the regional monthly PV report
• Provide root cause analysis (RCA) and CAPA for North America late reporting as applicable
• Ensure procedural deviations are appropriately documented.
• Oversee subset of quality review/quality management of Individual Case Safety Reports (CSRs)

Medical Inquiry (MI) Management:

• Ensure MIs are addressed in a timely manner as per internal procedures and address and support responses to MIs as needed

Exchange of Safety Information with Business Partners:

• Manage drafting, execution and maintenance of Safety Data Exchange Agreements (SDEAs)
• Negotiate SDEAs with BPs
• Review QA agreements and business contracts and review of PV obligations as per the SDEAs

SOPs training

• Develop Drug Safety Standard Operating Procedures and ensure training for Drug Safety personnel

Adverse Drug Experiences (ADEs) in North America

• ADE management per applicable procedures
• Ensure ADEs are forwarded to GPV for processing and ensure follow ups for ADEs are performed as applicable

Periodic reports

• Ensure review of periodic reports at US Drug Safety prior to submission to the FDA and approve periodic reports prior to submission
• Ensure review of Canada PSURs occurs by the Canada Drug Safety RPP or designee prior to PSUR finalization

Regulatory Report Submissions

Risk Management

Archival

People Engagement

Qualifications:

• PharmD, Master’s in Pharmaceutical Sciences or MD required
• 10-12 years’ experience in Pharmacovigilance or related field
• Supervisory experience required