If you have a medical degree and like using your analytical thinking we are looking for you to join our pharmacovigilance project. If you are interested in the evaluation, interpretation, and systemization of scientific data this position is just for you as we are looking for fresh graduates as well as professionals with experience in the Medical field interested in the area of Medicine and Pharmaceuticals.
About what you would be doing:
- Provide medical expertise and judgment throughout the case-handling process with medical review of individual cases.
- Ensure compliance with global and local procedural documents.
- Maintain knowledge of the marketed drug currently under litigation.
- Determine medically important events.
- Resolve queries relating to drug coding.
- Resolve queries relating to AE coding in MedDRA
- Help in constructing medically sound narratives.
- Help in defining the content of the PSUR comment.
- Solve the medical queries during the case handling by case handlers.
Requirements:
• Degrees: Medical degree
• Excellent written and verbal communication skills and ability to present and critically discuss clinical data in both internal and external discussions.
• Ability to evaluate, interpret and synthesize scientific data (analytical thinking)
Advantages:
- At least 2 years of experience working in area of degree qualification
- Two or more years of Drug Development/Patient Safety experience obtained while working in industry and/or academia.
- Knowledge of drug safety & clinical development and ICH/GCP principles
- Good knowledge of pharmacovigilance practices, particularly in relation to signal detection and evaluation.
- Good knowledge of US and EU pharmacovigilance regulatory requirements.
At TCS you will discover:
- A colorful and dynamic work environment with a great diversity of people, cultures and business areas
- An open culture that improves the quality of life
- Learning and sharing that helps you to progress both professionally and personally
Please note this position has a 1 year fixed term contract.
Medical Certificate or equivalent, English (Business Fluency)
Recommended Skills
Pharmacovigilance
Pre Clinical Development
Med Dra
Drug Development
Good Clinical Practices (Gcp)
Pharmaceuticals