Location: Barre,MA, USA
Job Overview:
Skills, Knowledge & Experience
- 10+ years of experience in Pharmacovigilance
- Clinical Research, Pharmacovigilance
- Good understanding of regulatory requirements and ICH-GCP guidelines
- Technical proficiency with Microsoft Office suite of applications
- Good Pharmacovigilance or Allied Pharmacovigilance understanding (cosmetovigilance/ consumer portfolio/ monographs/ medical devices etc.)
- Hands on Experience of managing a Medical Information Call Centre or Equivalent Call Centre
- Experience of having lead a team of Medical Information Call Centre of decent size (at least 40 member team) over at least 3 years in Manila
- Experience of mentoring Team Lead level personnel for at least 3 years in Manila
Key Competencies
- Process setup and creation expertise
- Experience in managing offshore operations and delivery in multiple/remote locations
- Workflow Management, Metrics Tracking & Reporting
- Process Orientation - understand and design process documents
- Experience in managing operations and offshore delivery
- Experience in managing performance
- Experience in transitioning processes
- Strong people management and leadership skills
- Excellent verbal and written communication skills
- Focus on quality
- Attention to detail
- Knowledge of quality management frameworks such as Six Sigma
- Strong Client Management skills and ability to support account mining activities
Working with different clients
- Planning and prioritizing
- Proactive risk identification and management
- Ability to multitask and work across work streams
Strategic
- Implement and promote use of consistent, efficient and quality processes to meet timelines and deliverables according to requirements and standard operating procedures, and assume accountability for the deliverables
- Ensure compliance of operations with governing regulatory requirements
- Create, maintain and assume accountability for a culture of high customer service
- Ensure delivery of services meets or exceeds Service Level Agreements through focused metrics management of process performance
Operational
- Accountable for managing delivery of service for the assigned engagement(s) as per the defined process and SLA
- Responsible for realization of revenue targets associated with the project under the remit of this role
- Responsible for profitability and other key service delivery related metrics
- Hiring, training, managing and retaining delivery resources
- Implement process & productivity improvements as appropriate to improve operational efficiency
- Execute plans and processes for improving service delivery and client satisfaction.
- Work closely with SMEs and QA to improve and exceed quality standards, to identify process improvements and to ensure delivery resources have necessary training and skills per industry norms
- Ensure that engagement is executed within agreed upon productivity and utilization metrics
- Generate reports, MIS, updates on service delivery, employee engagement, process improvements, etc. for timely reporting and enable decision making.
- Provide guidance and support to the team of Associates and TLs for proactive solution to the business issues.
- Provide timely information to finance for billing and revenue projections
- Support responding to particular sections of RFPs as required.
- Implement transition plan for new process engagements to establish delivery of service by Labcorp team.
- Review of training files for respective team members
- Additionally perform project specific activities like training and training documentation related activities as per project requirements.
Driving operations delivery
Creating a motivated work place environment
Identify possible attrition and work towards decreasing attrition rates
Drive optimal delivery from work task force
Drive productivity from work task force
Education/Qualifications:
Graduate or Post Graduate in Life Sciences Field
Trained and experienced in Good Clinical Practice
Trained and experienced in Pharmacovigilance
Experience:
- 10+ years of experience in Pharmacovigilance
- Hands on Experience of managing a Medical Information Call Centre or Equivalent Call Centre
- Experience of having lead a team of Medical Information Call Centre of decent size (at least 40 member team) over at least 3 years in Manila
- Experience of mentoring Team Lead level personnel for at least 3 years in Manila