Executive – Pharmacokinetics
Location: Bangalore, Karnataka, India
Organization: Apotex Inc.
Employment Type: Full-Time
Experience Required: 4–5 Years
Posted Date: March 11, 2026
Overview
Apotex Inc. is seeking a detail-oriented and analytical Executive – Pharmacokinetics to join its Bangalore team. This role focuses on pharmacokinetic analysis, clinical data management, and regulatory compliance aligned with global standards such as CDISC, GCP, and GLP. The position offers an opportunity to contribute to bioequivalence studies and global regulatory submissions within a dynamic pharmaceutical environment.
Key Responsibilities
Develop and generate SDTM and ADaM datasets in compliance with CDISC standards
Perform annotation of Case Report Forms (CRFs) for clinical studies
Develop and validate in-house SAS programs in line with regulatory and quality standards
Conduct validation and review of clinical trial datasets, including Define.xml specifications
Create datasets, tables, listings, and perform data comparisons and sorting
Perform pharmacokinetic and statistical analysis of concentration-time data for bioequivalence studies
Generate and review randomization schemes for clinical trials
Prepare and review pharmacokinetic and statistical sections of bio-study reports
Ensure compliance with global regulatory requirements such as USFDA, TPD, and EMEA
Respond to regulatory queries and track deficiencies with appropriate justifications
Support preparation of protocol synopses and review of CRO/in-house protocols
Assist in feasibility assessments for bioavailability and bioequivalence studies
Maintain and archive study-related documentation in coordination with QA teams
Adhere to SOPs, GCP, GLP, and company quality standards
Collaborate with cross-functional teams to achieve project goals
Educational Qualifications
Integrated Master’s Degree in Science (Pharmacokinetics, Pharmacology, Biostatistics, or related field)
Skills and Competencies
Strong knowledge of pharmacokinetics, biostatistics, and clinical data analysis
Proficiency in SAS programming and CDISC standards (SDTM, ADaM)
Understanding of global regulatory submission requirements
Excellent analytical and problem-solving skills
Strong written and verbal communication abilities
Ability to manage multiple priorities in a fast-paced environment
High attention to detail and accuracy
Team-oriented with adaptability and flexibility
Experience Required
Minimum 4–5 years of industry experience in pharmacokinetics, clinical data analysis, or bioequivalence studies
Experience in regulatory submissions for agencies such as USFDA, EMA, or Health Canada is preferred
Environment & Compliance
Exposure to global clinical research and regulatory frameworks
Work in a quality-driven and compliance-focused pharmaceutical environment
Emphasis on ethics, safety, and continuous improvement
About the Organization
Apotex Inc. is the largest Canadian-based pharmaceutical company, specializing in generic, biosimilar, and innovative medicines. With a strong global presence, the company is committed to improving access to high-quality healthcare solutions worldwide.
Diversity, Equity & Inclusion
Apotex is committed to creating an inclusive and accessible workplace where all employees are valued and supported. Reasonable accommodations are provided during the recruitment process for candidates with disabilities.
How to Apply
Interested candidates are encouraged to apply through the official Apotex careers portal or via your organization’s recruitment platform.
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