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

• Fostering a positive work environment by addressing team concerns, recognizing achievements, and facilitating problem-solving to maintain motivation and reduce turnover.
• Maintain technical and industry knowledge by attending and participating in applicable company-sponsored training.
• Preparing or reviewing periodic team reports (e.g., productivity summaries, compliance updates) for management or audits, ensuring transparency and accountability.
• Collaborating with medical reviewers, safety scientists, or regulatory affairs teams to ensure seamless communication and alignment on safety issues or reporting deadlines.

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

• Strong motivational skills and abilities, promoting a team-based approach
• Strong interpersonal and communication skills, both verbal and written in English (and/or as applicable)
• Strong organizational and leadership skills
• Goal-oriented
• Ability to maintain professional and positive attitude
• Attending and participating in applicable company-sponsored trainings