Position: Executive – Biopharmaceutics (Clinical Research)
Location: R&D Centre, Gandhinagar, Gujarat
Department: Biopharmaceutics (Clinical Research)
Qualifications:
- Degree: M.Pharm (Pharmacology)
- Experience: 2 to 5 years in Clinical Research
Key Responsibilities:
- Conduct feasibility assessments and evaluate new products.
- Perform literature reviews and design BA/BE (Bioavailability/Bioequivalence) studies.
- Monitor Bioequivalence (BE) studies.
- Prepare documents for regulatory submissions (e.g., BENOC, Import License applications).
- Establish and maintain study documentation.
- Prepare dossier submission documents (including Clinical Overview, Non-Clinical Overview, and Summary Tables).
- Review BE study documents such as protocols, reports, Informed Consent Forms (ICF), etc.
- Prepare and review medical and scientific write-ups.
- Coordinate the reporting of serious adverse events (SAEs) and provide safety updates to regulatory agencies.
Interested candidates may send their resumes to:
- Megha Maheshwari: meghamaheshwari@torrentpharma.com
- Vilsha Shah: vilshashah@torrentpharma.com