Project Manager, Drug Safety

Job Description

Essential Duties and Responsibilities:

As a Project Manager

• 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

  Other 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

Specialized knowledge and skills:

• 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

  Communication skills:

• Requires a proactive approach and excellent written/oral communication and interpersonal skills.
• Strong interpersonal skills required to interact with clients, management, and peers effectively.
• Effective cross - department communication. Ability to document and communicate problem/resolution and information/action plans.

  Technical skills:

• Person should be familiar with MS Office tools/Data base and other applicable software.
• Ability to educate/ train the team members as needed.
• Contributing to the ongoing enhancement of Pharmacovigilance process and SOP s including internal and external training.
• Maintaining Pharmacovigilance systems including global safety database.

  Other skills:

  The ability to contribute to a team environment with a high degree of professionalism and skill. Demonstrated flexibility within a dynamic, fast - paced, cross - functional team. Demonstrated ability to complete multiple tasks concurrently and deliver results in a fast - paced environment. Ability to perform under stringent timelines. working conditions: Normal office environment.

  Compliance:

  Awareness of organizational policies & procedures governing his/her job responsibilities. Awareness and compliance of QMS & ISMS policies & procedures and their impact at his/her job level. Should understand escalation matrix and escalate to the next level whenever incidents happen which are not in compliance with organizational, QMS & ISMS policies and procedures.

  Working Conditions: Normal office environment.

  Hours:

  Standard Hours 40 hours per week, one hour lunch, Monday - Friday. Additional hours as needed.

  Willing to work in shifts as and when needed

Keyskills :
delivery projectmanagement customerrelations reporting java subjectmatterexpertise stronginterpersonalskills msoffice dataentry drugsafety followingup lifesciences drugdevelopment peoplemanagement customerhandling corporateliaison presenta