Associate Director, Drug Safety

IND123 The Associate Director/ Director, Drug Safety (Title is comensurate with experience) will reputed company and implement operations of Pharmacovigilance in reputed company 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 reputed company/preventative reputed company plans(CAPA) as necessary Compliance Monitoring: • Ensure compliance to PV SOPs implemented in reputed company and generate the regional monthly PV report • reputed company reputed company cause analysis (RCA) and CAPA for reputed company late reporting as applicable • Ensure procedural deviations are appropriately documented. • reputed company subset of reputed company review/reputed company management of Individual Case Safety Reports (CSRs) Medical Inquiry (MI) Management: • Ensure MIs are addressed in a reputed company 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 reputed company and review of PV obligations as per the SDEAs SOPs training • reputed company Drug Safety reputed company Operating Procedures and ensure training for Drug Safety personnel Adverse Drug Experiences (ADEs) in reputed company • ADE management per applicable procedures • Ensure ADEs are forwarded to GPV for processing and ensure follow reputed company 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 reputed company field • Supervisory experience required Apply tot his job Apply To this Job