Drug safety Associate Jobs in Mysore - BIOCLINICA
Job Description
- Job Title : Drug Safety Associate / Senior Drug Safety Associates
- Location: Mysore
- Years of Experience: 0 to 5 years
- Qualification : B Pharmacy, M Pharmacy, Pharm D, BDS, MDS, BSc Nursing, MSc Nursing, BAMS, BHMS
Essential Duties and Responsibilities:
As Case Intake Member:
- Responsible for case intake, duplicate check , and registration
- Maintain log of source documents and other communications
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.
As Literature Review Specialist
- Ensure effective and accurate collection, recording, review and reporting of literature searches conducted.
- Review of literature articles to identify case safety reports.
- Responsible for operational Pharmacovigilance activities for assigned developmental and/or marketed products.
- Assist in signal generation and safety analysis activities.
- Ensure quality of literature searches and reporting.
- Review of local/global literature reports to determine regional reportability.
- Create/maintain study summary documents.
- Assist with narrative writing for periodic/ad hoc submissions.
- Assist with ad hoc or routine safety monitoring activities.
- Following up with sites regarding outstanding queries.
- Follow up on reconciliation of discrepancies.
- Follow departmental AE workflow procedures
- Closure and deletion of cases
- Perform any other drug safety related activities as assigned
- Perform literature review activities when trained and assigned.
- 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 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.
COMMUNICATION SKILLS:
- 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.
OTHER SKILLS:
- 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.
Job Particulars
About Company
BIOCLINICA () is a global specialty clinical trials services provider delivering expertise and technologies to enhance clinical research, data and analytics . Bioclinica delivers focused service supporting multifaceted technologies such as Medical Imaging, Cardiac safety services, Molecular marker laboratory, Drug Safety and Regulatory solutions, Network of research sites, patient recruitment-retention services, and a post-approval research division.
Bioclinica serves more than 400 pharmaceutical, biotechnology, and device organizations – including all of the top 20 – through a network of offices in the U.S., Europe and Asia . Bioclinica’s primary locations include:
Newtown,
Pennsylvania – Global Headquarters
Audubon, Pennsylvania – eClinical Solutions Division
Princeton, New Jersey – Medical Imaging and Cardiac Safety Division
Newark, California – Medical Imaging
Portland, Oregon – Medical Imaging
Lyon, France – Regional Office
Munich, Germany – Regional Office
London, England – Regional Office
Shanghai, China – Regional Office
Tokyo, Japan – Regional Office
Mysore, India
Bangalore, India