Apotex is a proudly Canadian, global pharmaceutical company that produces high-quality, affordable medicines (both generic and innovative pharmaceuticals) for patients around the world. We are the 7th largest generic pharmaceutical company globally with more than 12,000 employees and estimated sales of approximately $3 billion. Our fully integrated operation is comprised of four lines of business: Global Generics; Apobiologix; Global Active Pharmaceutical Ingredients (API); and ApoPharma (Innovative Products). With our worldwide manufacturing sites, Apotex can produce up to 24 billion dosages per year.
Post : Associate, GMA RD6-GRA-GMA S
Job Description
Job Summary
Working independently under the direction of the Head - Global Medical Affairs, GBS, 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
• 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.
• Regular interactions with Regulators such as Health Canada, FDA, and other competent Authorities in the EU and Australia to address toxicological issues in New Product Submissions and Marketed Products.
• 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.
Candidate Profile
• Master of Veterinary Science, M.Pharm,
• Certification- Diplomat American Board of Toxicology (preferred)
• 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.
• >5-7 years of experience either in Toxicology CRO, Pharmaceutical industries, Consumer safety assessment.
Additional Information
Experience : 5 years
Qualification : M.Sc, M.Pharm
Location : Mumbai
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : GMA RD6-GRA-GMA S
End Date : 20th January, 2020
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