Lead Executive - Drug Information and Risk Management

Job Summary

Working independently under the direction of the Deputy Manager- Global Medical Affairs, brings toxicological expertise in the Risk Assessment process to support risk assessment and Health Hazard Assessment (HHA) activities for the business as required. Major stakeholders are Research and Development, Quality Assurance, Safety Health & Environment and others.

Job Responsibilities

Primary Responsibilities:

• Conducts Health Hazard Assessments in a timely manner upon request with a high level of autonomy.
• Actively conducts risk assessment activities for a variety of situations from a toxicological perspective when needed.
• Establishes acceptable and/or tolerable daily intakes for substances in question through review or calculations.  
• Identifies No Observed Effect Levels (NOEL) and No Observed Adverse Effect Levels (NOAEL), Lethal Dose 50 (LD50) etc.
• Generates reports with a toxicological conclusion for the assessment in question based on the literature, the circumstances and the results of studies, if undertaken, based on sound toxicological science.
• Supports Safety, Health and Environment with toxicological assessments when requested.
• Supports business units in GRDQ such as Global Project Management, Quality Assurance, Formulation Development, Analytical Operations etc. bringing toxicological expertise to bear.
• Ensures good regulatory compliance.

Additional Responsibilities:

• Works as a member of a team to achieve all outcomes.
• Performs all work in support of our Corporate Values of Collaboration, Courage, Perseverance, Passion; Demonstrates strong and visible support of our values.
• Performs all work in accordance with all established regulatory and compliance and safety requirements.
• Utilize open, honest, two way communication to build trust-based relationships with employees, business partners and direct leader while continuously improving capabilities by personally seeking feedback and development.
• All other duties as assigned.

Job Requirements

• Education
  • Master of Pharmacy in Pharmacology, M. Pharm,
  • Bachelor of Pharmacy, B. Pharm
• Knowledge, Skills and Abilities
  • General and Regulatory toxicology, Risk characterization, safety assessment, Consumer products, Good Laboratory Practice, as a toxicologist in the area of drug development.
  • Good knowledge and skill in toxicological testing procedures for pesticides, new chemical entities, IND requirements.
  • Good knowledge and skill in risk assessment procedures for Medical products/Medical devices.
• Experience
  • 5-7 years of experience in Toxicology CRO and Pharmaceutical industries.