Rohit Bodkhe – Unlocking the Secrets of Pharmacovigilance: A Journey Through Clinical Research and Drug Discovery!

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**Rohit Bodkhe**
**Male**
**Indian**
**27th December, 2000**

**CONTACT ADDRESS**
**Kulshree PG**
**Laxman nagar, Baner, Baner-Balewadi road,**
**Pune- 411045**

**Permanent Address**
**Plot no 24, Osmanpura,**
**Aurangabad, Maharashtra-431001**

**CAREER OBJECTIVE**
Self-motivated, highly passionate and hardworking Fresher looking for an opportunity to work in a challenging organization to utilize my skills and knowledge.

**AREA OF INTEREST**
– Pharmacovigilence, Clinical Data Management and Clinical Research.
– Regulatory affairs related to clinical trials and pharmacovigilance (ICH-GCP, FDA, EMA guidelines).

**EDUCATIONAL QUALIFICATION**

| Course | Institution | University/Board | Year of Passing | Aggregate (%)/C.G.P.A. |
|————|——————–|——————–|—————–|————————-|
| M.Sc Biotechnology | Modern College of Arts, Science and Commerce, Pune | Savitribai Phule Pune University | 2025 | – |
| B.Sc Biotechnology | Mahatma Gandhi Mission, Aurangabad | Dr. Babasaheb Ambedkar Marathwada University | 2023 | 69.77% |
| Intermediate (10 + 2) | Vidyadham College Maharashtra education of secondary and higher secondary | 2019 | 54.77 |
| High School (10th) | Anant Bhalerao Vidya Mandir | State Board | 2017 | 74.80 |

**PROJECT WORK**
1. Isolation, Identification and Antifungal Activity Of Air Microflora in Microbiology laboratory
2. Structure-based drug discovery: screening natural compounds for BACE1inhibition in Alzheimer’s disease.

**TRAINING**
1. Internship at GREENARRAY- Genomic Research & Solutions Private Limited
2. Completed Clinical Data Management training from Biotecnika, covering data entry, query handling, and ICH-GCP guidelines. Gained practical understanding of CDM tools.

**WORKSHOP**
1. Hands-on training workshop on Molecular cloning at Agharkar Research Institute
2. Three Dimensions of Stem Cells- Drug Discovery, Drug Screening and Drug Delivery at Modern College
3. Molecular docking at SPPU.

**TECHNICAL SKILLS**
– Electronic Data Capture (EDC) systems (e.g., Medidata Rave, Oracle InForm)
– Query Management and Resolution
– SDTM and CDASH Standards
– SAE Reconciliation
– Clinical Database Design and UAT
– ICH GCP & 21 CFR Part 11 Compliance

**STRENGTHS**
– Self-confidence
– Highly Ambitious
– Punctuality
– Positive attitude
– Strong understanding
– Communication skill
– Fast learner and connect with new people
– Excited to learn new things
– Team Collaboration

**DECLARATION**
I hereby state that all the above information is true to the best of my knowledge.
**PLACE: PUNE** **Rohit Bodkhe**
**DATE:**

**Keywords: Pharmacovigilence, Clinical Data Management, Regulatory Affairs, Drug Discovery, ICH-GCP, FDA, EMA, Molecular Cloning, Stem Cells, Molecular Docking, Electronic Data Capture, SDTM, CDASH, SAE Reconciliation, Clinical Database Design, ICH GCP, 21 CFR Part 11 Compliance.**
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Cover Letter:

Of course! Please provide me with the data that you would like me to redact.

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