Venkateshram S.

About Venkateshram S.

QUALIFICATION HIGHLIGHTS: • Motivated physician with diverse medical training including primary care and a variety medical subspecialties. • Expertise in global pharmacovigilance, patient safety, regulatory compliance, and GCP guidelines. • Knowledgeable on adverse event reporting, case processing of AE/SAEs, signal detection, and aggregate reporting. • Experienced in writing SUSAR, PSUR, PBRER, and DSUR reports and contributing to IND and NDA safety reporting. • Practiced in contributing to and utilizing signal detection plans, risk management plans, and mitigation plans. • Strong command of the clinical development process, safety surveillance, and quality management. • Ability to combine medical training with knowledge of pharmacodynamics, pharmacokinetics, and drug interactions. • Adept at processing safety cases with an emphasis on timeliness, quality data, and regulatory compliance. • Proficient in preparing MedWatch (3500A) and CIOMS forms and utilizing MedDRA and WHODD coding. • Thorough knowledge of FDA, CFR, GCP-ICH, and EU-EMA/GVP drug safety and pharmacovigilance regulations. • Strong focus on collaboration with exceptional leadership, communication, and relationship building skills. • Detail-oriented, versatile, passionate, motivated, organized, accountable, disciplined, and a creative problem solver. KEY COMPETENCIES: Clinical Research • Clinical Development • Patient Safety • Pharmacovigilance • Global Drug Safety Regulatory Guidelines • GCP/GMP/GLP Guidelines • ICH Guidelines • FDA/EMEA Requirements Clinical Documentation • Regulatory Compliance • Quality Management • Safety Surveillance Signal Detection Plans • Adverse Event Reporting (AE) • Serious Adverse Events (SAE) Individual Case Safety Reports (ICSR) • Risk Management Plans • Aggregate Reporting • Argus Database MedDRA Coding • WHODD Coding • SUSAR/PSUR/PBRER/DSUR • IND/NDA Applications Clinical Protocols • Informed Consent Forms (ICF) • Investigational Brochures (IB)

Experience

1. Pharmacovigilance Scientist

   Sollers College

   Mar 2020 — Present · Edison, NJ, US

   Led research projects to monitor and ensure compliance with global drug safety and regulatory requirements.• Worked with Psychiatry, Oncology, Neurology, Cardiology, Gastroenterology, and Endocrinology clinical data.• Performed safety case processing of adverse events and serious adverse events generating case receipt numbers.• Assessed Case Reports for seriousness, causality, and expectedness using global inspection method.• Reviewed AE/SAE reports and processed ICSR from data entry to medical review for serious and non-serious AEs.• Conducted quality audits on AE reports to ensure accurate data entry and processing from source documents. • Processed safety cases with an emphasis on timeliness, quality data, and regulatory compliance.• Ensured case processing and reports adhered to applicable regulations, guidelines, SOPs and project requirements.• Utilized MedDRA (23.0) and WHODD drug coding dictionaries to code cases and wrote narratives for SAE reports.• Created electronic reports for new cases and performed case book in and data entry in Argus Safety Database.• Wrote regulatory reports including ICSR, SUSAR, PSUR/PBRER, DSUR, and aggregate reports. • Supported safety data reporting for Investigational New Drug and New Drug Applications. • Contributed to the development and oversight of the signal detection plan and safety surveillance activities.• Identified and assessed safety observations, emergent safety concerns, and new safety signals. • Ensured timely communication of confirmed safety signals to regulatory authorities and all key stakeholders.• Assessed safety data from sources including clinical trials, spontaneous and solicited reports, and literature reports.• Served as subject matter expert for vendors providing drug safety and pharmacovigilance services.• Assisted with medical guidance on writing and review of clinical trial protocols, ICFs, and IBs.• Contributed to RMPs, Risk Evaluation and Mitigation Strategies.

Education

• Strayer University

  Master of Health Administration

• Dowling College

  Bachelor of Arts - BA

• University of Sciences, Arts and Technology

  Doctor of Medicine - MD