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At Quintil
es we help healthcare and biopharma companies improve their probability of success. We do this by connecting our scientific, therapeutic and analytics expertise with superior delivery. From advisory through operations, Quintiles and its affiliate companies is the world’s largest provider of product development and integrated healthcare services. As one of FORTUNE’s ‘Most Admired Companies’ in 2016, we offer great opportunities for a career in world-leading clinical research. Our global projects, innovative tools and industry leading customers combined with outstanding support from our leadership team and clear career mapping allows you to make a difference in patient health.Job Title : Safety Associate Trainee
Job ID – 1714976
Location : Bangalore
Description
PURPOSE
- Review, assess and process Safety data and information, across service lines, received from various sources and distribute reports/data onwards to both internal and external third parties following applicable regulations SOPs and internal guidelines under guidance and support of senior operation team members.
RESPONSIBILITIES
- To Prioritize and complete the assigned trainings on time.
- Process Safety data according to applicable regulations, guidelines, Standard Operating procedures (SOPs) and project requirements.
- To perform Pharmacovigilance activities per project requirement including but not limited to, collecting and tracking incoming Adverse Events(AE)/endpoint information; determining initial/update status of incoming events; database entry; coding AE and
- Products, writing narratives, Literature related activities.
- Assuming other workflow responsibilities for the assigned project as directed by
- Operations team member or Manager.
- Ensure to meet the expected productivity and quality standards
- Ability to identify quality problems, if any, and bring them to the attention of a senior team member/ mentor.
- Attend project team meetings and provide feedback to operations manager on any challenges/issues or successes.
- Perform other duties as assigned.
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
- Good knowledge of medical terminology
- Strong verbal/written communication skills.
- Ability to work as a Team Player, contribute and work towards achieving Team goals
- Good working knowledge of Microsoft Office and web-based applications
- Self-motivated and flexible
- Attention to detail and accuracy
- Ability to follow instructions/guidelines, utilize initiative and work independently
- Ability to manage competing priorities and deadlines
- Willingness and aptitude to learn new skills across Safety service lines
- Strong time management skills
Qualifications
MINIMUM REQUIRED EDUCATION AND EXPERIENCE : Bachelor’s degree in life sciences or related field with up to 6 months experience or equivalent combination of education, training and experience.
PHYSICAL REQUIREMENTS
- Extensive use of keyboard requiring repetitive motion of fingers.
- Extensive use of telephone and face-to-face communication requiring accurate perception of speech.
- Regular sitting for extended periods of time.
- May require occasional travel.