Ranjit Ravindran Email & Phone Number

Basel, Basel-Stadt, Ch

Mumbai, Maharashtra, In

Basel, Baselstadt, Ch

Basel, Baselstadt, Ch

Basel, Baselstadt, Ch

Manage contracted pharmacovigilance services outsourced to External Service Providers covering all operational aspects (contractual, operational, financial performance, metrics, forecasting).Responsible for ESP governance meetings, issues / escalation management, transitions to ESP and adherence to Global ESP GOP.Facilitate and manage effective communication at senior leadership levels between the two organizations for accuracy, completeness and integrity of business.Support/Lead partner organizations during audits and inspections for logistics, documentation, CAPAs and corresponding audit compliance with closure of finding (if any).Act as delegate for Global Head, PV Operations on Outsourcing and Vendor Management

Basel, Baselstadt, Ch

Strategic and operational aspects of CMO and patient safety through Contracting, Due Diligence (including quality assessments and vendor selection), Governance, Oversight, Metrics and Invoice management.Design and implement the vendor/partner performance management tools and systems in consultation with the different stakeholders from both the partner organizations including Technical, QA, IT, Procurement, Finance and others.Act as a liaison between the functional and operational teams for exchange of ideas/ proposals/ target assignments for their completion and logical conclusion to achieve highest efficiency, productivity and compliance in safety information reporting (ICSR, Aggregate Reports, Medical Function, Data Management, Safety System, IT infrastructure etc.) for Novartis.Responsible for External Service Provider (ESP) business continuity planResponsible for oversight of Information Security & Risk Management (ISRM) & Data Integrity & Privacy

Basel, Baselstadt, Ch

Ensure top compliance with global pharmacovigilance agreements by regular compliance analysis, reporting and communication, including corrective action oversight, monitoring and verification of database configuration requirements, maintenance of other accurate listings and assistance in agreement maintenance/updates.Ensuring regular reconciliation and documentation of exchanged reports with global licensing parties.Author monthly compliance and reconciliation reports, including trend-analyses, for exchange of individual case reports, and other written safety documents between global licensing parties, for both incoming and outgoing information.Regularly reviews expediting requirements and organize verification of corresponding database configuration.Assist in pharmacovigilance agreement updates.

Basel, Baselstadt, Ch

Therapeutic Area Coordination (team management)Site Case Correction Coordination. (Case Correction team management).Internal and External Audit coordination (02 Audits).Preparation of Management metrics (resource allocation and productivity).Class Room Training and Mentoring new hires.Receive information on adverse events, perform initial checks, search database to prevent duplicate entries, create case file and initialize received drug safety reports in the DS&E tracking tool and/or safety databaseEnsure scientific rigor through accurate, complete and consistent data entry of adverse event reports from source documents with emphasis on timeliness and quality.Evaluate and finish processing of non-expeditable AE reports, including review for completeness and accuracy.Use medical dictionaries and business guidance’s to code medical history, drugs and adverse event terms. Prepare narratives summarizing the essential details of the case.Identify clinically relevant information missing from case report and facilitate its collection (in consultation with medical staff as required) by preparing follow-up request as needed.Alert manager to potential safety signals based on incoming case reports.Work with Novartis country safety departments, Clinical Safety Scientists and Pharmacovigilance Leaders to ensure that reports are accurately collected, evaluated and data based.Assist with related administrative and procedural activities as required or requested.Assists in the training of other Safety Processing Experts as necessary.Support ad hoc projects and/or database validation activities as required.

B.Tech, Biotechnology

Post Graduate Diploma In Clinical Research, Clinical Research