Pharmacovigilance Services Assoc Manager

 About The Role  

Skill required: Pharmacovigilance Operations - Pharmacovigilance & Drug Safety Surveillance

Designation: Pharmacovigilance Services Assoc Manager

Qualifications:MBBS/MD

Years of Experience:10 to 14 years

What would you do? Oversee responsibilities in delivering service to the client including mobilization of resources required in delivering the service and managing their performance. Working closely with the client project lead and operations lead to manage risks, issues, and escalations and drive successful project completion with high quality.

What are we looking for? Educational and Experience Requirements:?¢Graduate in life sciences. ?¢Prior experience in managing large teams for pharmacovigilance or clinical data management functions. ?¢Creative approach to problem solving and good lateral thinking skills. ?¢Good leadership abilities. ?¢Efficient on Excel and Microsoft PowerPoint?¢High energy and drive to lead large teams. ?¢Comfortable working in a dynamic business environment Other essential duties include drafting pharmacovigilance agendas and meeting minutes; accurately archiving pharmacovigilance documents; reviewing safety case data and other pharmacovigilance documents for completeness and accuracy; submitting and distributing of reports; assisting liaisons with the partners and cross-functional team members to ensure compliance; supporting various ad-hoc deliverables or pharmacovigilance projects; and participating in audits and inspections.Key performance indicators ?¢Ability to communicate effectively. ?¢Ability to operate in a metrics driven environment. ?¢Ability to plan, organize, and allocate optimal number of resources to deliver business results. ?¢Ability to measure team??s performance, analyze data, and take appropriate actions. ?¢Ability to provide effective feedback, coaching and career development opportunities for staff. ?¢Ability to guide staff in issue resolutions and provide direction as to the proper escalation process. ?¢Ability to manage day-to-day interaction/ coordination with client where required (system downtime, project deliverables, timelines, issue escalations, etc.). ?¢Ability to drive projects to completion with high quality and timelines.

Roles and Responsibilities: Resource management?¢Coordination and Supervision - Coordinate, manage and monitor workings of various processes in the organization. ?¢Best Practices - Improve processes and policies in support of organizational goals. Monitor adherence to rules, regulations, and procedures. ?¢Perform the literature QC lead activities as outlined in the Client SOP. ?¢Monitor submission gap reports and coordinate with Global case processing associate to complete the pending case submissions as per Client SOP.?¢Production - Coordinate and monitor the work of various sections involved in production, monitor performance, and implement improvements. Provide technical support where necessary. ?¢Facilitate coordination and communication between support functions.?¢Strategic Input - Liaison with senior management. Assist in the development of strategic plans for operational activity. Implement and manage operational plans. ?¢Work with HR and recruitment to ensure timely mobilization of manpower (including definition of JDs and selection of candidates). ?¢Planning and allocation on the day-to-day activities in the project ?¢Ensure adherence to output targets at desired quality levels. ?¢Analyze MIS and take corrective action where required.Staff Management & Development ?¢Recruit, hire and reward high performing individuals to meet goals. Facilitate resource evaluation needs across sites. ?¢Ensure team members receive the necessary training to perform their job functions effectively and consistently within regulations.?¢Manage both internal and external stakeholders ensuring the challenges are tackled efficiently. Process & Technology ?¢Understand and work to the current divisional/departmental SOPs, ensuring deviations are documented appropriately. Propose new and revise current procedures as appropriate. ?¢Lead and work with the teams to optimize processes and use of pharmacovigilance-related technology to build a more efficient organization. Encourage practical applications of new ideas. ?¢Formulate decisions and prioritize implementation of enhancements. Client Management ?¢Ensure adherence to client??s policies and procedures.?¢Maintain procedures in adherence to the client??s policies. ?¢Ensure all the client SLAs and KPIs are met.?¢Assist in audit and inspections.?¢Ensure all relevant governance documents (slides and minutes) are archived in the respective folders.?¢Contribute, review, and approve applicable documents. ?¢Initiate SLA/KPI approvals and generate relevant reports.?¢Approve Literature Full text ordering requirement if needed as per the process
 Qualification MBBS,MD