Pavan Kumar Pg Email & Phone Number

Bengaluru, Karnataka, India

● Vendor Management & Compliance: Support vendors to ensure productivity, quality, and compliance with SOPs in all literature-related activities, including managing a product list, mapping sheet, and shared-INN literature to ensure accurate global surveillance.● Global Literature Subject Matter Expert (SME): Support local literature and provide SME support to affiliates globally by maintaining and monitoring the Literature mailbox and responding to ad-hoc requests. Led literature retrieval and triage for safety surveillance and case management, ensuring alignment with business and regulatory requirements.● Training & Development: Conduct comprehensive training on databases, SOPs, pharmacovigilance, and clinical development to enhance team flexibility and productivity. Actively participate in literature tool and SOPs training for vendors.● Cross-functional Collaboration: Coordinate with cross-functional teams and technology platforms to meet business needs, track deviations, and manage CAPA processes.● Audit & Inspection Readiness: Led literature-related activities during audits and inspections, ensuring compliance with regulatory requirements as the Literature Surveillance SME. ● Customer Engagement & Satisfaction: Respond promptly and accurately to unsolicited verbal and written medical literature inquiries from HCPs and consumers, consistently meeting or exceeding customer satisfaction objectives.

Bengaluru, Karnataka, India

• Developed and communicated the product vision and strategic direction to align with business goals.• Created, prioritized, and managed the product backlog, ensuring continuous refinement and updates based on user feedback, market changes, and business needs.• Collaborated with stakeholders, customers, and the development team to gather and define user requirements in the form of clear and actionable user stories.• Determined the priority of user stories and features, considering business value, customer needs, market demands, and technical constraints.• Actively participated in sprint planning meetings, selecting user stories for each sprint and providing requirements clarification to the development team.• Conducted sprint reviews and demos, gathering feedback from stakeholders and customers to ensure the product increment met their expectations.• Proactively communicated with stakeholders, customers, and team members, serving as the primary point of contact for product-related inquiries and concerns.• Ensured the creation and maintenance of essential product documentation, including user manuals, release notes, and product guides.• Made timely and informed decisions regarding the product, including scope changes, feature trade-offs, and addressing issues or risks during development.• Fostered collaboration and provided leadership to cross-functional teams, fostering a shared understanding of product goals and requirements.

Bengaluru, Karnataka, India

• Manage customer interface and communication for assigned projects under guidance from senior team members. Represent CEVA on projects; serve as primary or back-up point of contact within CEVA for all internal and external customers, as assigned.• Manage deliverables for assigned projects under guidance from senior team members. Responsibilities include project planning (i.e., timelines, deliverables, resourcing, central files, and archiving records), defining / managing project scope, and quality management under guidance from senior team members.• Develop, finalize, and distribute all project-specific CEVA documents. Design all necessary programmed reports and listings under the guidance of CEVA management.• Work closely with internal and / or external partners to manage development, testing, and use of electronic systems necessary for CEVA project processes.• Attend meetings with internal and external stakeholders under guidance of senior team members as needed. Provide project status updates; define processes, and project planning/strategy.• Read and acknowledge all necessary IQVIA standard operating procedures (SOPs) and customer SOPs as required.• Ensure all required training is executed within a timelines and documented. Ensure individual training plan and training transcript reconcile.

Bengaluru, Karnataka, India

• Screened, analyzed, and reviewed medical and scientific literature articles to substantiate safety and efficacy content.• Performed literature review, identified potential signal detections for marketed products, developed search strings and screened abstracts for inclusion and exclusion criteria.• Performed day-to-day activities of ICSR case processing for the literature ICSRs (Completion of full case in the database, including quality review to ensure accuracy and completeness)• Performed the quality checks on review and assessment articles• Participated in the yearly review of product trade, compound and generic name• Participate in the yearly validation review of literature search strategy• Provided project/new product-related mentoring/training about literature search strategies and signal detection to new joiners.• Served as a liaison between the company and the patients or healthcare experts to provide valid information on product safety.

Bengaluru Area, India

• Performed initial receipt, registry, triage of cases to determine the seriousness and upgrade the cases in the workflow step.• Performed assessment of case reports for seriousness, causality and expectedness.• Performed literature searches to identify adverse events for inclusion in the worldwide safety database.• Performed and processed quality review of spontaneous, literature and clinical trial cases.• Performed literature search and review supporting activities, such as requesting deletions, addition of new code list terms, admin edit, preparing deviation memos, nullification, and MOMs.• Prepared presentations on processing related procedure for all type of cases and on new transitioned drugs• Participated in client meetings / project specific training sessions.

Bengaluru Area, India

• Performed literature curation, semantic indexing, search review, and analytics of literature articles.• Data abstraction and scientific writing• Performed data extraction of trial design, treatments, demographics, and outcome data from the clinical literature.• Performed data extraction from full-text articles, graphs for biomarkers, efficacy, and safety outcomes• Performed analysis of adverse drug reactions in a disease condition from literature articles• Abstraction of Japanese patents or articles to provide in-depth analysis of drugs and molecular substances.

Master Of Science, Biotechnology

Master Of Science (Msc), Biotechnology

Bachelor Of Science - Bs, Biotechnology