Job title: Drug Safety Scientist II
Job description: PRIMARY RESPONSIBILITIES
As a Drug Safety Scientist, II:
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
Education: Any Healthcare Professional (BPharm/Mpharm/Pharm D/BHMS/BAMS, etc.) with MBA is desirable.
Experience: 5-6 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
Travel: 0-50% (can be adjusted)
Lifting: 0-50 lbs. (can be adjusted)
Other: Computer work for long periods of time
THIS JOB DESCRIPTION SHOULD NOT BE DEEMED ALL-INCLUSIVE. ADDITIONAL REQUIREMENTS AND EXPECTATIONS MAY BE ASSIGNED. AT ALL TIMES, EMPLOYEES ARE EXPECTED TO ADHERE TO COMPANY POLICIES AND COMPANY SOPS.
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. ,
Location: Mysore, Karnataka
Job date: Mon, 09 Nov 2020 23:15:40 GMT
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