Bioclinica is utilizing data and technology to enable more efficient trial conduct. We are looking at ways to reduce the size of the trials, provide greater clarity into the effect of the drug, and to reduce the amount of complexity in the trial. We do this by improving trial design and utilizing advanced analytics to identify patients who would be high responders for a particular clinical trial.
Post : Drug Safety Scientist I
As Quality Check Reviewer
• Review and evaluate AE case information to determine required action based on and following internal policies and procedures.
• Process current incoming cases in order to meet timelines.
• Provide guidance for Data entry & Quality teams.
• Following up with sites regarding outstanding queries.
• Follow-up on reconciliation discrepancies.
• Follow departmental AE workflow procedures.
• Train and mentor new team members as per requirements of the project.
• Delegate tasks and responsibilities to appropriate personnel
• Identify and resolve issues and conflicts within the project team
• Act as guide, coach and counselor for the team
• Following up with sites regarding outstanding queries and reconciliation of discrepancies
• Closure and deletion of cases
• Follow departmental AE workflow procedures
• Oversee, mentor and guide the activities of the Drug Safety and Senior Drug Safety Associates
• High level of proficiency at all workflow tasks
• Perform any other drug safety related activities as assigned
• Subject Matter Expertise in Safety database
• Must have good presentation skills and the ability to give presentations.
• Knowledge of the Life Sciences Industry a plus.
• Experience in entire drug development life cycle.
• Relevant product and industry knowledge
• Experience with relevant safety databases and software applications.
• Person should be familiar with MS Office tools/Data base and other applicable software.
• Ability to educate/ train the team members as needed.
• Maintaining Pharmacovigilance systems including global safety database
• Any Healthcare Professional (BPharm/Mpharm/Pharm D/BHMS/BAMS, etc.) with MBA is desirable.
• 4-5 years of experience in Pharmacovigilance.
• Strong motivational skills and abilities, promoting a team-based approach
• Strong interpersonal and communication skills, both verbal and written
• Strong organizational and leadership skills
• Ability to maintain professional and positive attitude
Location : Mysore, India
Industry Type : Pharma / Biotech / Clinical Research
Functional Area : Drug Safety
End Date : 20th June, 2021
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