Vikas Kumar Email & Phone Number

Mumbai, Maharashtra, India

Mumbai, Maharashtra, India

# Managing global PV activities including but limited to (PSMF, SDEA, Aggregate Reports (e.g. PSUR, PBRER, DSUR, PADER, and AdCO), RMP, Signal, Safety variation, Regulatory intelligence, Reconciliation, Compliance report, Vendor Management, respond to Regulatory Request/Query related to safety# Managing daily deliverables tracking and provide SME support # Suggesting process simplification and improvement plan for PV activities# Imparting training to stakeholders as applicable# Coordinating with different stakeholders, both internal and external across globe, for fulfilment of PV responsibilities # Communicating new or changed regulations to management, to service provider, and to relevant members of the department in order to initiate any change in processes# Managing team associated with pharmacovigilance-related activities# Preparing internal reports and other reports requested by the management related to the achievements & managing new development plans, renew and develop in-house group effort# Executing evaluation of the process/procedures to find out gaps and liaising with business for its mitigation and improvement plan# Monitoring PV activities conducted by service provider; providing assistance in budget preparation# Conducting corporate team meeting (CTM) to present quarterly status of Pharmacovigilance# Drafting and revising different PV documents (SOP, WI, Organogram, Training slide)# Reviewing and finalizing Service Level Agreement (SLA) and Pharmacovigilance Management Plan (PMP)# Conducting audit of the business partners and service providers# Facing audit from business partners, and inspections from regulatory authorities# Mentoring & coaching the project team; planning and integrating the work of team on a project; providing input on team performance and reward# Providing action plans to implement operational excellence# Steering diverse responsibilities, including strategy planning & execution, new initiatives

Hyderabad, Telangana, India

# Conducted data collection and liaised with stakeholders # Scheduled, wrote, reviewed, and tracked PSUR, PBRER, IBRER, PADER, AdCO, and RMP # Prepared response to observation/recommendation, pertaining to PSUR review letter from CDSCO (India) # Reviewed Health Hazard Assessment (HHA) reports

Mumbai, Maharashtra, India

# Managed the SDEA globally (writing, reviewing, revision, termination, negotiation, liaising with stakeholders, tracking & archiving, implementation, & compliance); acted as SPOC and SME for SDEA # Wrote and reviewed PSUR, PBRER, RMP, PSMF/PvMF# Submitted Article 57 product information to xEVMPD # Performed regulatory intelligence activity to keep track record of all safety guidelines, regulations, and recommendations # Prepared PV compliance report for QPPV oversight of the system, on monthly basis# Revised safety sections of EU SmPC and PIL in line with reference innovator/recommendation from regulatory authorities, and communicated with the Regulatory Affairs (RA) team on safety variations filing# Performed periodic reconciliation with subsidiaries, affiliates, service providers, business partners, and inter-departments# Prepared response to Regulatory Authority’ query/request related to safety# Prepared and revised SOP and work instruction (WI)# Conducted vendor management activity

Mumbai Area, India

# Performed activities related to data mining and review of the FDA adverse event reporting system (FAERS) and Database of Adverse Event Notification (DAEN) # Drafted PBRER and RMP# Drafted SDEA, exchanged safety information and performed periodic reconciliation with business partners# Imparted SOP training to applicable stakeholders# Executed reconciliation of ICSRs received from various sources # Conducted data correction of ICSRs identified while preparing aggregate reports, signal reports, health hazard assessment reports (HHA), routine signal reviews, post-process quality checks (PPQC), and FAERS review # Reviewed the operational practices, and identified the areas of quality failures & process errors; advised on system & process changes for quality improvement by raising Change Control Request (CCR)# Took monthly teleconferences with Lupin’s subsidiaries in the USA, Germany, Brazil, South Africa, Mexico, and the Philippines

Mumbai Area, India

# Quality Review of ICSRs

Mumbai

# Processing of ICSRs

Mysuru Area, India

# Quality review of ICSR

Delhi

# Processing of ICSRs

Bachelor Of Pharmacy (B.Pharm.), Pharmaceutical Sciences, First

P.G.D In Clinical Research &Pharmacovigilance, Clinical Research, First