Nashid Karim

• Manages business partner/customer Pharmacovigilance agreements to ensure they are in place and up to date..
• Act as primary point of contact for business partner/customer drug safety & product quality complaint reporting.
• Oversee and track compliance to PV agreements and customer complaint reporting utilizing Trackwise Quality Management system.
• Act as Lead investigator to non-conformance or issue related to PV agreement business partner/customer obligation compliance.
• Identify and investigate the non-compliance/issues, develop root cause analysis (RCA) and implement effective corrective actions & preventative action (CAPA).
• Tracks adherence of CAPA timelines.
• Perform routine CAPA effectiveness checks.
• Undertakes trend analysis of non-conformance in PV agreement obligations and reports upon this.
• Initiates and tracks change control related to PV agreement obligations.
• Oversee business partner/customer reconciliation activities monthly, quarterly and annually to ensure completion in a timely manner.
• Monitors and coordinates the ongoing status of PV Agreement and initiating renewals or updates as required with business Partners.
• Leads the development and maintenance of SOPs and training documents related to PV Agreements,

• Created, negotiated & implemented over 100 new PV contracts with various local and International contractual partners using specialized vendor management system-SAP ARIBA.
• Maintained over 400 PV contracts with contractual business partners in SAP-ARIBA.
• Managed oversight of affiliate (Australia, Mexico, EU, Middle East) task and responsibilities related to PVAs and reconciliation.
• Delegated reconciliation and PV contracts assignments to affiliate colleagues.
• Collaborated & communicated contractual obligations to internal stakeholders-Quality assurance, Medical Information, Regulatory Affairs, Legal, Business Development (BD), and New Product Launch (NPL) team etc.
• Tailored and aligned PV clauses according to country specific regulatory requirements- FDA, Health Canada, EMA, etc.
• Supported internal BD and NPL team to launch new pipeline products in the market by timely completing PV contracts with contractual partners.
• Actively participated in FDA, Health Canada, EMA & MHRA PV inspections.
• Performed routine reconciliation activities with over 100 Contractual Partners in-line with related SDEA/PVA.
• Coached, trained and mentored new hires, interns/students & team members.

• Performed medical & quality review of over 30 ICSRs per day which included but not limited to MedDRA
• coding assessment, causality assessment, seriousness assessment, listedness assessment etc.
• Contributed to timely submissions of ICSRs to competent Health authorities- Health Canada, FDA, EMA
• etc.
• Conducted extensive literature assessment for AE/ADRs and medical review of articles.
• Assisted in the preparation, review and evaluation of signals, aggregate reports and risk management plans.
• Assisted in the maintenance of SOPs, Safety Data Exchange agreements with business partners and internal work instructions.
• Contributed to process improvement initiatives in consultation with management.