Associate Ii, Patient Safety

6 days ago

Bengaluru Karnataka, India Alcon Full time

Evaluates and understands pharmacokinetic/pharmacodynamic (PK/PD) characteristics absorption, distribution, metabolism and excretion (ADME) research on compounds, and associated variability of drugs in non-clinical and clinical development, using empiric, mechanistic and population modeling approaches. Embraces model-based drug development (MBDD) - a mathematical and statistical approach that constructs, validates, and utilizes disease, placebo, exposure-response, and pharmacometric models to evaluate risk and facilitate drug development, in close collaboration with R&D partners. Applies PK/PD techniques/aspects during all stages of drug development including molecule selection, non-clinical dose and regimen selection, first-in-human studies, Phase II dose/regimen selection and strategic and tactical decision-making for the large Phase III clinical studies. Focuses on the evaluation and implementation of innovative trial designs to enhance the efficiency and provide better informed decision making.

Excellent listening ability and communication skills
Excellent decision quality and negotiation skills
Ability to manage multiple tasks, attention to detail, prioritize work and manage time well
Knowledge and understanding of national and international medical device regulations and regulatory guidelines
Knowledge of medical aspects of medical device safety, medical device vigilance in pre
- and post-marketing safety practice
Basic knowledge of MS Office

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Alcon is an Equal Opportunity Employer and takes pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity, marital status, disability, or any other reason.

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