Hiring Organization / Company: Bioclinica
Basic Salary: To Be Discussed
Employement Type: Full-Time
Essential Duties and Responsibilities:
As Quality Check Reviewer
- Review data entered in safety database for completeness and accuracy.
- Provide quality feedback to team resources
- Track and maintain quality metrics
As Case Processor
- Responsible for data entry of Individual case safety reports into the safety database.
- Review and evaluate AE case information to determine required action based on and following internal policies and procedures.
- Process all incoming cases in order to meet timelines.
- Full data entry including medical coding and safety narrative.
As Medical Coder
- Responsible for coding all medical history, events, drugs /procedures/indications and laboratory tests according to the appropriate dictionary (For e.g. MedDRA, Company Product Dictionary, WHO-DD).
As Narrative Writer
- Responsible for writing medically relevant safety narrative of cases and checking the completeness and accuracy of the data entered in the various fields.
- Following up with sites regarding outstanding queries.
- Follow up on reconciliation of discrepancies.
- Follow departmental AE workflow procedures.
- Closure and deletion of cases.
- Mentor and guide the activities of the Dug Safety Associate.
- High level of proficiency al all workflow tasks.
- Perform any other drug safety related activities as assigned.
Specialized knowledge and skills:
- Basic competence with medical and therapeutic terminology.
- Ability to work independently but guided by documented procedures, with appropriate support.
- Able to work effectively as part of a team.
- Understanding of patient safety regulatory obligations.
- Should be familiar with regulatory &pharmacovigilance guidelines.
- Should be familiar with pharmacovigilance terminology.
- Excellent attention to detail.
- Ability to deliver within established timelines.
- Fluency in English and excellent comprehension.
- Computer literate.
- Relevant product and industry knowledge.
- Experience with relevant software applications.
- Requires a proactive approach and excellent written/oral communication and interpersonal skills.
- Strong interpersonal skills required to interact with clients, management, and peers effectively.
- Effective cross‑department communication.
- Ability to document and communicate problem/resolution and information/action plans.
Desired technical skills:
- Person should be familiar with MS Office Tools.
- Safety database knowledge.
The ability to contribute to a team environment with a high degree of professionalism and skill. Demonstrate flexibility within a dynamic, fast-paced, cross-functional team. Demonstrated ability to complete multiple tasks concurrently and deliver results in a fast-paced environment. Ability to perform under stringent timelines.
Awareness of organizational policies & procedures governing his/her job responsibilities. Awareness and compliance of QMS & ISMS policies & procedures and their impact at his/her job level. Should understand escalation matrix and escalate to the next level whenever incidents happen which are not in compliance with organizational, QMS & ISMS policies and procedures.
Working Conditions: Normal office environment.
Standard Hours 40 hours per week, one hour lunch, Monday – Friday. Additional hours as needed.
Bioclinica is an equal opportunity employer. Bioclinica evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status, or any other legally protected characteristic.Collaboration, Continuous Learning, Critical Thinking, Organizational Awareness, Results Orientation, Service Orientation
Job Location Information:
Location: Mysore, Karnataka
Share this job on:
Top 10 Tips When Finding a Job
If that you’re not kidding about in search of Jobs, you’re going to agree that it is likely one of the hardest jobs at the moment. Typically, you are going to haven’t any clue the place or what to look for in the job market. The good thing is that you are not by yourself. There are a few other folks out there who are jobless like you. Finding a job even in a industrial center can be simple if you understand the place to start out. Before you begin your job looking procedure, listed below are tips to help you to find your dream job.
1. Job Facilities
Job companies are an unbelievable and frequently lost sight of hots pot for finding Jobs. Job firms regularly provide vital training, property, and techniques for process seekers. These companies can also be specifically helpful for young job seekers or the ones with little working revel in. A simple Web experiment for job firms to your areamust uncover the place and the right way to get to them.
2. Temporal companies
Many firms choose to have their positions dispatched through temporal companies. The top function for that may be to save cash on consultant benefits like healthcare. Temporally agencies likewise supply corporations the way of screening applicants. Employment services can often be a sooner and not more daunting job than finding direct employment. An employment company might likewise change into into a long-lasting activity for the individuals who perform neatly all the way through their working.
3. Free job look services and products
This is a waste of money while money is now tight within the first place. After all, the money you pay for job searching websites is imposed deductible if you’re on a job. It’s smarter to use the money to pay for expenses.
4. Look at the nearby school
When finding a job, never forget your school. Some schools additionally have coordinate contract positions, so check with them can be useful in finding a new career. If you talk with your teachers, they will be on the lookout for positions that match your training and experience. Some schools may need you to go to their offices for an informal interview. Here you can step through an examination on their PC. You’ll talk with a recruiter to examine exactly what you want.
Newspapers are often an overlooked apparatus for finding Jobs. Smaller businesses still use newspapers as their method when looking for Job applicants. Most newspapers will have their job listings online too. Some may ask the companies to have the listings online. There could be listings in the paper that don’t appear online.
6. Foot hunts
If that you are tired by ineffective attempts at finding a job using one of the above methods, getting out and looking for employers will yield better results. Showing up in person often demonstrates determination and initiative that most employers will find alluring in a potential representative.
7. Online Forums
Joining online forums is another good way of finding your new job. Here you will get companies that are ready to hire you and work with you. Make sure that you join as many online job finding as possible. Ensure that you describe your profile well so that your employers can know who you are.
8. Look at corporate websites
Most corporate websites are good places that can give a job. Look for websites and companies which you would love work with. On the careers page find out if there an open vacancy which matches your expertise. You can also send an email to the HR and ask for consideration.
9. Ask friends
Friends are the best at finding jobs. Before you go out, call all your friends and ask if they have any job connections that match your skills. In most cases, the job search connection will be wide and at last, you will land on one vacancy.
10. Make application regularly
Never be tired of applying. Make sure that you keep on applying for the new jobs that are posted every day. Avoid mentioning that you have done ten applications so far.
When finding a Job, don’t waste time on applications that are complicated for a job you don’t know if you want. Don’t open positions that are not exactly what you want. Tap on them thinking that it may be an approach to get your foot in the entryway.