Pharmacokinetics Executive

2 weeks ago

Bengaluru, Karnataka, India Apotex Full time

About Apotex Inc.

Apotex Inc. is a global health company that produces high-quality, affordable medicines for patients worldwide. With a presence in over 75 countries, Apotex employs almost 7,200 people in manufacturing, R&D, and commercial operations.

Job Summary

The Executive - Pharmacokinetics role is responsible for implementing CDISC standards in compliance with regulatory requirements and managing key activities of data management, software development, and validation. This includes performing pharmacokinetics and statistical analysis of concentration-time data and generating randomization schemes as needed.

Key Responsibilities

  • Creating SDTM and ADaM datasets for Apotex studies using CDISC standards
  • Annotation of CRFs for clinical studies conducted by Apotex
  • Development and validation of in-house SAS programs in line with quality standards and regulations
  • Ensuring software validation is done in line with applicable company quality standards and regulations
  • Validation and review of clinical trial data
  • Creation of specifications for Define.xml, validation, and review of SDTM, ADaM, and Define.xml
  • Creating data sets, tables, listings, and procedural comparisons, sorting of source data
  • Ensuring assigned work is performed in accordance with GCP, GLP, SOPs, regulatory requirements, best practices, and established safety standards
  • Preparing justification for queries from regulatory agencies and tracking of regulatory deficiencies
  • Conducting pharmacokinetic and statistical analysis of concentration-time data of bioequivalence studies in compliance with SOPs
  • Generating/reviewing randomization schemes
  • Preparing and/or reviewing 100% snapshot data
  • Preparing and reviewing the pharmacokinetic/statistical section of Bio-study Reports in accordance with different regulatory guidance
  • Preparing Protocol Synopses and reviewing in-house and CRO Protocols
  • Preparing comprehensive summaries of pharmacology/toxicology information and other documents necessary for regulatory submission
  • Assisting in study feasibility exercises for new projects to conduct bioavailability and bioequivalence studies
  • Requesting and maintaining controlled copies, including coordination with QA teams
  • Maintaining, updating, and archiving study-related files and documents
  • Working as a member of a team to achieve all outcomes
  • Working in a safe manner, collaborating as a team member to achieve all outcomes
  • Demonstrating behaviors that exhibit our organizational values: Collaboration, Courage, Perseverance, and Passion
  • Ensuring personal adherence to all compliance programs, including the Global Business Ethics and Compliance Program, Global Quality policies and procedures, Safety and Environment policies, and HR policies
  • All other relevant duties as assigned

Requirements

  • Education: Integrated Master's Degree in science
  • Knowledge, Skills, and Abilities: Expertise in statistical analysis, SAS, and/or bio-statistics; excellent communication and interpersonal skills; flexible to work
  • Experience: At least 4-5 years of industry experience in clinical trials related submissions for different regulatory agencies

At Apotex, we are committed to fostering an inclusive, accessible work environment where all employees feel valued, respected, and supported.

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