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Drug Safety Operations Lead

5.00 to 6.00 Years   Mysore   12 Dec, 2021
Job LocationMysore
EducationNot Mentioned
SalaryNot Disclosed
IndustryFMCG / F&B
Functional AreaGeneral / Other Software
EmploymentTypeFull-time

Job Description

  • Supervision and coordination of following activities:
  • Lead and manage the project to comply with the SOW and SLAs.
  • Supervise all project related activities.
  • Single point of contact between the team and the client for smooth functioning of the project.
  • Communicate between the management and the team.
  • Record, maintain and track the metrics for both team members and project performance.
  • 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.
  • 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.
  • Act as a management level liaison between Client and Bioclinica Project team
  • Coordinate and manage administrative project issues
  • Delegate tasks and responsibilities to appropriate personnel
  • Identify and resolve issues and conflicts within the project team
  • Recruit select and train team members
  • Act as guide, coach and counselor for the team
Secondary Responsibilities
  • 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
  • Proven experience in customer handling and relationship.
  • Proven ability to perform task management.
  • Proven People management skills.
  • 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
QualificationsEducation: Any Healthcare professional (B pharm / M pharm / Pharm D or any other equivalent qualification)Experience: 5-6 years of experience in PharmacovigilanceAdditional Skills
  • Strong motivational skills and abilities, promoting a team-based approach
  • Strong interpersonal and communication skills, both verbal and written
  • Strong organizational and leadership skills
  • Goal-oriented
  • Ability to maintain professional and positive attitude
,

Keyskills :
drug safetylife sciencesdrug developmentpeople managementcustomer handlingcritical thinkingcorporate liaisonpresentation skillsservice orientation

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