Jayapaul B

About Jayapaul B

Experienced professional in global patient safety activities in both developmental & post approval phases of product life cycle meeting regulatory compliance.DEVELOPMENTAL SAFETY: Overall experience incl. end to end Clinical study safety incl. safety strategy, study design, contibution to CSP, ICF, DMC, SRC charters, CSR, 2.5, 2.7.4, clinical interpretation of study results through TFLs, presentstion at safety governance, Involved in other safety governances for e.g, prep for Investment Desicions etc Previous exp incl. SAE/SUSAR processing, reporting of SUSAR, authoring DSURs, work on SUSAR LLPOST-APPROVAL SAFETY: Overall exp. incl. end to end Global PV activities including case processing & reporting of ICSRs, routine safety surveillance (signal management), Safety Governance for CDS updates, author & review of Safety review reports, author & review of PSUR/PBRER, PADERs & ACOsBENEFIT-RISK ASSESSMENT; SME for structured Benefit-Risk: sBR Methodologies, Guide and help teams with sBRRISK MANAGEMENT PLANS: Exp RMPs; aRMM, exp in REMS and REMS defense.HA RESPONSES: Questions from HAs on CTA, MAA, safety variations, safety topics, PSUSA assessments, pAR, RSI/RFI etcAGREEMENTS: SDEAs with third party distributors, Divestment/MA Transfer agreements & Techincal Agreements with QPPVs & Local Responsible persons.MICC: Coordinate with MICC for F/U info, Targeted questionnaires, draft product FAQs and trainning MICC associates. Answering to HCP/non HCP queries via MICC.QMS: Creation & maintenance of PV SOPs, safety procedures, manuals & work instructions. Participate in audits/Inspections (Internal & External)AUDITS & INSPECTIONS: Faced US FDA inspections twice, Ghana FDA inspection, QPPV audit, Third party audit and internal audits, preparation of Audit responses and initiate CAPA activitiesHA INTERACTIONS: Backroom expert for FDA Adcomm, EMA scientific advisory committee, F2F meeting with SAHPRA (South Africa)TECHNICAL: Hands on experience on safety DBs like Argus & ARISg, reporting of ICSRs to authorities via ESM. Clinical DBs like RAVE, INFORM, DATALABS. Submission of PADERs via ESG & EU PSURs via esubmission portal, set up ESG connection with trading partners (HAs), project/study set up in safety DB, LSSRM (AgSignal). Hands on experience on Business Objects and Oracle Analytics.ARTIFICIAL INTELLIGENCE: Deploy AI tools such as ChatGPT, Copilot Studio, Notebook LM with proficiency in prompts and use of Agentic AI into day-to-day activities/tasks project management, improve productivity, reduce time on laborious tasks.

Experience

1. Associate Director-senior Patient Safety Scientist

   AstraZeneca

   Oct 2025 — Present · Bengaluru, IN

Education

• Bharath Institute of Technology

  M.PHARMACY, Dept of Pharmaceutics

  2008 — 2010

• Aditya Institute of Pharmaceutical Sciences & Research

  Bachelor, B.PHARMACY

  2004 — 2008

• St. Gabriels High School

  S.S.C

  1989 — 2001

• Nava Vignana Bharathi Junior College

  Intermediate, Bi.P.C

  2001 — 2003

Skills

• Regulatory Affairs
• Argus Safety
• Pharmacovigilance
• Pharmaceutical Research
• Validation
• Regulatory Submissions
• Arisg
• Pharmaceutical Industry
• Sop
• Drug Delivery
• Life Sciences
• Ich-Gcp
• Gcp
• Pharmaceutics
• Clinical Trials
• Good Pharmacovigilance Practice Modules
• Clinical Research
• Clinical Pharmacology
• Pharmacology
• Formulation
• Pharmacokinetics