Banu Shaik
@banushaik
PharmD-trained Clinical Research Associate combining GLP auditing, GCP documentation, and pharmacovigilance experience.
What I'm looking for
I’m a PharmD graduate trained in GCP, and I bring a quality-first mindset shaped by GLP auditing and regulatory documentation practice. I want to turn careful clinical training into reliable trial execution, stronger compliance, and safer decision-making.
At Palamur Biosciences, I audited acute to 9-month toxicology studies across rodent and non-rodent models. I strengthened inspection readiness through rigorous documentation review, CAPA support, deviation management, and a strong focus on study protocols and data integrity.
Through my training at CPA-Institute of Pharmaceuticals & Life Sciences, I practiced pharmacovigilance reporting (ICSRs, PSURs) and used systems such as Oracle Clinical and MedDRA. I also authored mock protocols and Clinical Study Reports aligned with ICH-GCP, FDA, and EMA standards.
In hospital settings, I supported quality through prescription audits and treatment chart reviews, flagging adverse drug reactions and drug-drug interactions early. I’ve also led a prospective study on prescription patterns for Acne Vulgaris and authored 4 peer-reviewed publications, reinforcing the scientific writing precision I apply to protocols and submissions.
Experience
Work history, roles, and key accomplishments
Research associate (Quality Assurance Auditor)
Jun 2025 - Jul 2026 (1 year 1 month)
Audited acute, 14-day, 28-day, 90-day, and 9-month toxicology studies in rodent and non-rodent models. Ensured compliance with SOPs, GLP principles, and study protocols. Supported CAPA, deviation management, data integrity, and inspection readiness. Collaborated with Study Directors and cross-functional teams to maintain quality compliance.
Research Associate - QA
Palamur Biosciences
Jun 2025 - Jul 2026 (1 year 1 month)
Audited acute, 14-day, 28-day, 90-day, and 9-month toxicology studies in rodent and non-rodent models. Ensured GLP/SOP and study protocol compliance, supporting CAPA, deviation management, data integrity, and inspection readiness.
Trainee Clinical Research & Regulatory Affairs Specialist
Jan 2025 - Apr 2025 (3 months)
Completed intensive practical training in clinical trial monitoring, pharmacovigilance reporting (ICSRs, PSURs), and data management systems (e.g., Oracle Clinical, MedDRA).
Authored mock protocols and CSRs (Clinical Study Reports).
Gained familiarity with ICH-GCP, FDA, and EMA regulatory guidelines.
Collaborated with peers on simulated submissions to regulatory authorities.
Clinical Research & RA Trainee
CPA-Institute of Pharmaceuticals & Life Sciences
Jan 2025 - Apr 2025 (3 months)
Completed practical training in clinical trial monitoring, pharmacovigilance reporting, and clinical data management. Authored mock protocols and Clinical Study Reports aligned with ICH-GCP and FDA/EMA regulatory guidance.
Hospital Research Intern
Sri Balaji Hospital and Research Institute
Apr 2024 - Mar 2025 (11 months)
Reviewed treatment charts to identify potential medical errors, adverse drug reactions, drug-drug interactions, and medication appropriateness. Conducted prescription audits across hospital departments and supported pharmacovigilance reporting and patient counseling.
Reviewing treatment charts for potential medical errors, adverse drug reactions, drug- drug interactions, and the appropriateness of prescribed medications.
Conducting Prescription audits across various hospital departments.
Reporting adverse drug reactions to the pharmacovigilance cell. Provided comprehensive patient counseling on disease conditions, treatment plans, and lifestyle modificatio
Education
Degrees, certifications, and relevant coursework
Krishna Teja Pharmacy College, Tirupati
Doctor of Pharmacy - PharmD, Pharmacy
2019 - 2025
Doctor of Pharmacy (Pharm.D) is a professional doctoral degree focused on clinical pharmacy, pharmacotherapy, and patient-centered care. It equips graduates with in-depth knowledge of drug therapy, disease management, and healthcare systems, enabling them to play a key role in optimizing medication use and improving patient outcomes.
Krishna Teja Pharmacy College
Doctor of Pharmacy (Pharm.D), Pharmacy
2019 - 2025
Doctor of Pharmacy (Pharm.D) is a professional doctoral program focused on clinical pharmacy, pharmacotherapy, and patient-centered care. It trained you in drug therapy, disease management, and optimizing medication use to improve patient outcomes.
Sri Chaitanya college vijayawada
Intermediate , Bipc
2018 - 2019
studied BIPC in sri chaitanya junior college and gained knowledge in biology terminologies
Swami Vivekananda school
Secondary school , SSC
2016 - 2017
studied SSC in Sri Swamy Vivekananda High School in Srikalahasti
Tech stack
Software and tools used professionally
Availability
Location
Authorized to work in
Job categories
Skills
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