Clinical trials are complex and monolithic approaches are the norm. But the most successful trials require the ability to see key details and uncover hidden insights. Bioclinica creates clarity in the clinical development process, and we are looking for passionate professionals who are ready to share their knowledge and innovation to support successful clinical trials.
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Bioclinica is an agile organization with more than 2,500 colleagues around the globe – and growing! Our expansive footprint and domains of expertise afford plenty of opportunities to be challenged, to succeed, and to advance your career whether looking for that first job or your next big career move.
Our dynamic team is unified by our strongly held values: shared Success through passion, knowledge, and innovation.
Position: Drug Safety Operation Lead
Location: Mysore, Karnataka, India
• Supervision and coordination of the 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 the 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 the 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 a 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
• 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 the entire drug development life cycle.
• Relevant product and industry knowledge
• Experience with relevant safety databases and software applications
• 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 a professional and positive attitude
Qualification: B pharm / M pharm / Pharm D or any other equivalent qualification
Experience: 5-6 years of experience in Pharmacovigilance