PRIMARY RESPONSIBILITIES
As a service delivery 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
SECONDARY RESPONSIBILITIES
- Person should be familiar with MS Office Tools.
- 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.
- 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
QUALIFICATIONS
Education: Any healthcare professional (B Pharm / M Pharm / MBA or any equivalent qualification)
Experience: 8-10 years of experience in Pharmacovigilance / Pharmaceutical / Clinical research.
Additional Skills
- Strong motivational skills and abilities, promoting a team-based approach
- Strong interpersonal and communication skills, both verbal and written
- Strong organizational and leadership skills
- Goal-oriented
- Ability to maintain professional and positive attitude
WORKING CONDITIONS
Travel: 0-50% (can be adjusted)
Lifting: 0-50 lbs. (can be adjusted)
Other: Computer work for long periods of time
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 andexternal 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.
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.
WORKING CONDITIONS
Travel: 0-50% (can be adjusted)
Lifting: 0-50 lbs. (can be adjusted)
Other: Computer work for long periods of time
THIS JOB DESCRIPTION SHOULD NOT BE DEEMED ALL-INCLUSIVE. ADDITIONAL REQUIREMENTS AND EXPECTATIONS MAY BE ASSIGNED. AT ALL TIMES, EMPLOYEES ARE EXPECTED TO ADHERE TO COMPANY POLICIES AND COMPANY SOPS.
EEO Statement
Qinecsa is an equal opportunity employer. Qinecsa evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status, or any other legally protected characteristic.