QPS Bioserve India is hiring for a Research Analyst position in Hyderabad, Telangana. The role involves clinical study protocol preparation, clinical study reports, regulatory documentation, pharmacokinetic and pharmacodynamic studies, and pharmacy activities related to bioavailability and bioequivalence studies.
Candidates with B.Pharm or M.Pharm qualifications can apply for this full-time, permanent opportunity.
Job Details
| Particulars | Details |
|---|---|
| Company | QPS Bioserve India |
| Job Title | Research Analyst |
| Location | Hyderabad, India |
| Experience | 0–5 years |
| Qualification | B.Pharm / M.Pharm |
| Employment Type | Full-time, Permanent |
| Department | Research & Development |
| Industry | Clinical Research / Contract Research |
| Role Category | Pharmaceutical & Biotechnology |
| Openings | 1 |
Position
Research Analyst – Clinical Research
The position covers clinical documentation, protocol and report preparation, regulatory guideline review, and investigational product management for bioavailability and bioequivalence studies.
Roles and Responsibilities
1. Study Synopsis and Protocol Preparation
- Prepare and compile clinical study protocol synopses.
- Prepare and review clinical study protocols according to sponsor requirements and applicable regulatory authorities.
- Prepare informed consent forms.
2. Clinical Study Reports and Regulatory Documentation
- Prepare and review clinical study reports in accordance with sponsor and regulatory requirements.
- Prepare and review bio-summary tables, clinical summaries, and CSBE for regulatory submissions.
- Review scientific and technical inputs for pharmacokinetic and pharmacodynamic studies.
- Review regulatory guidelines and current requirements for clinical research-related activities.
3. Pharmacy Activities
- Dispense investigational drug products according to randomization schedules for bioavailability and bioequivalence studies.
- Issue investigational products to the clinical unit before dosing.
- Collect unused investigational products and store them in the pharmacy.
- Review procedures for pharmacy operations.
Eligibility and Qualifications
Candidates must have one of the following qualifications:
- B.Pharm – Bachelor of Pharmacy
- M.Pharm – Master of Pharmacy
The position is open to candidates with 0–5 years of experience.
Required Skills
The key skills associated with this Research Analyst job include:
- Clinical protocols
- Bioequivalence studies
- Clinical study reports
- Regulatory guidelines
- Clinical research
- Biotechnology
- Bio-summary tables
- Clinical trials
- Business research