Project Manager – Pharmacovigilance / Drug Safety
Experience Required: 6 – 12 Years
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
- 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
- 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.
- 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.
- 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