Skip to main content
Banu ShaikBS
Open to opportunities

Banu Shaik

@banushaik

PharmD-trained Clinical Research Associate combining GLP auditing, GCP documentation, and pharmacovigilance experience.

India
Message

What I'm looking for

I’m looking for a GCP-focused role where I can coordinate clinical trials, protect clinical data integrity, and support pharmacovigilance and regulatory documentation with quality-driven collaboration and continuous learning.

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

Palamur Biosciences logoPB

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.

CPA-Institute of Pharmaceuticals & Life Sciences logoCS

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.

sri balaji hospital and research institute renigunta logoSR

Student Intern

Apr 2024 - Mar 2025 (11 months)

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

KT

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.

KC

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.

SV

Sri Chaitanya college vijayawada

Intermediate , Bipc

2018 - 2019

studied BIPC in sri chaitanya junior college and gained knowledge in biology terminologies

SS

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

Get matched with your dream remote job

Sign up now and join over 250,000+ remote workers who receive personalized job alerts, curated job matches, and more for free!

Sign up
Himalayas profile for an example user named Frankie Sullivan