Manager - MICC

Job Title : MICC Drug Safety Operations Manager (DSOM)

Primary Responsibilities

• Client Engagement : Responsible for customer satisfaction and growth of the account.
• Deployment : Monitors the project closely throughout the engagement with the customer and keeps close contact with customer.
• Resource management : As a leader of people and teams, manages the team’s expectations and their growth within the organization.
• Manage day-to-day client interaction.
• Track and report project metrics / reports to the Client and Qinecsa senior management daily
• Create, execute, review and revise project plans, as required.
• Prepare for regular and ad hoc project review meetings.
• Ensure that project team members are appropriately trained on all relevant Qinecsa and Client SOPs, guidelines and documents, as required.
• Identify and resolve issues and conflicts within the project team.
• Preparation and Maintenance of Business Continuity Plan.
• First point of contact while executing Business Continuity Plan.
• Review and approve call abandon reports.
• Proactively initiate actions to address project related issues or delays
• Co-ordination with Qinecsa QA and to ensure logging of QER in Qinecsa’s Master Control and notify internal and external stakeholders
• Review and approve deviations / QER and CAPAs
• Conduct spot checks to track the project status and proactively initiate actions to address them.
• Ensuring Client team compliance with all relevant Client and Qinecsa SOPs.
• Ensure daily status updates on the project are provided to Client (abandon calls data, follow up tracker, quality review tracker, document archival, IRMS logs, email Client. The status of these reports to be verified in scheduled weekly and monthly meetings with Client.
• Responsible to ensure Data archival is performed in a timely manner to ensure no project related data is lost.

SECONDARY RESPONSIBILITIES

Qualifications

Education : Qualified to degree level in Biosciences or an appropriate healthcare or pharmaceutical industry background.

Experience : 5-6 years’ experience in Pharmacovigilance (MICC).

Additional Skills