Prashant Kathuria

• Manage safety of drugs belonging therapeutic area of oncology and transplant; Managing safety related aspects for a CTD submission for an additional indication for US-FDA for transplant therapy product
• Provides PV expertise for products, Maintains PV expertise and understanding of international safety regulations and guidelines
• Provides and maintains PV and risk management expertise to internal and external customers
• Maintains knowledge of product, their environment and recent literature
• Communicates and represents PV data evaluation, interpretation and summary or conclusions as relevant
• Responsible for signal detection and analysis as well as review, preparation, and/or contribution to responses to questions from health authorities, ethics committees, Internal Review Boards (IRBs), external partners
• Manages product safety alerts, as needed
• Responsible for Identifying and implementing proactive safety analysis strategies to further define the safety profile of the product
• Provides proactive risk assessment
• Responsible for documenting, coordinating, reviewing and validating periodic reports, e g: RMP update, IND Annual Report, Annual Safety Report/Development Safety Update Report, Periodic Safety Update Report, Health Hazard Evaluation etc., leads the preparation of clinical overview to support labeling changes and oversees the safety part of the Company Core Safety Information (CCSI) creation.

Technical competence

· Medical review of periodic (PBRERs), renewal (ADCOs) and DSURs reports for EU region as per latest GVP module.

· Medical Review of Signal Evaluation Reports and Risk Management Plans, ICSRs (Individual Case Safety Reports)

· Assessment of literature articles for processing in database.

· Audit / Inspection preparedness and successful accomplishment of multiple audits

· Revision of relevant Standard Operating Procedures / Work Instructions related to PV

· Quality Lead for Pharmacovigilance department – Establishment of quality systems, draft and review of Quality SOPs, completion of CAPAs and ICs

Managerial competence

· Recruitment of employees as per FTE requirement

· Provide inputs / escalation to higher management regarding the issues which require approval / decision making from head of pharmacovigilance

· Performance appraisals of employees

· Resolution of problems and conflicts among the team members

· Decision making in setting up objectives (Short term and long term) of associates

· Lead in people development group. Responsible for professional development of seven associates and inputs / guidance to approx. 50 associates

· Managed the PSUR team of six employees (One deputy manager, one team leader, Four Pharmacovigilance associates).

· Medical review of periodic (PSURs) and renewal (ADCOs) reports for EU region as per latest GVP module.

· Handling day-to-day issues pertaining to PSUR collation.

· Liaison with internal / external stakeholders for routine issues relating the data sharing, calendar updates, etc.

· Medical review of ICSRs (Individual Case Safety Reports) in database (ARISg).

· To conduct the follow-ups of ICSRs received spontaneously to the European Client.

· Assessment of literature articles for processing in database.

· Medical review of Signal Evaluation Reports and Risk Management Plans

· Revision of relevant SOPs.

· Manage four associates including three medical reviewers.

· Medical review of Serious Adverse Events received from Clinical trials.

· Draft, medical review and quality review of PSURs of all regions (including as per latest GVP module, PBRERs and Addendum to Clinical Overviews) except US (PADERS).

· Draft of relevant SOPs.

· Regional Administrator for Region II (EEA) PSURs - Maintaining Calendar, Ensuring Submission Compliance, Availability of RSIs and handling day-to-day issues with RPPs.

· Regional Co-administrator of Region III (IDRA, Australia, Ukraine, Singapore) PSURs - Maintaining Calendar, Ensuring Submission Compliance, Availability of RSIs and Handling day-to-day issues with RPPs.

· Random medical review of PSURs as a part of Quality Matrix.