CAC India : Pharma Operations
||Team Manager (Pharmacovigilance, Clinical Data Management, Medical coding)
||Project Manager and Deputy Project Manager (Operations)
||Mumbai / Pune
||Coordinate processing of project data received from worldwide clinical trials, Post marketing studies and compassionate use programs and manage operations to deliver high quality of work in field of business processing across all the projects
||As per company policy. Some overtime as required
Key Result Areas:
||Reporting adverse events in compliance with regulatory requirements and company SOPs whenever necessary
|Clinical Data Management
||Manage the data interpretations and queries
|| ICD-9-CM, ICD-10-CM/PCS, and CPT coding; billing and regulatory compliance, healthcare reimbursement methodologies
|Required Education and Experience
- Bachelor of Science degree or Master’s degree required or University degree in pharmaceutical sciences or other relevant medical or scientific disciplines preferred
- Minimum of 8-9 years drug safety experience
- Physician Assistant or related healthcare experience preferred
- Pharmaceutical industry experience preferred; Drug Safety case processing experience highly desirable
- More than 5-6 years leadership experience
- More than 3-4 years of people management experience
Essential Competencies (Knowledge, Skills and Attributes):
- Working knowledge of relevant regulations and guidance documents governing both safety reporting and processing for clinical trial and post-marketing environment
- Report writing skills prepare high quality documents
- Effective verbal and written communication in individual and group settings
- Strong organizational skills, detail oriented, ability to adapt in a fast paced constantly changing environment
- Good knowledge of medical terminology highly desirable
- Ability to analyse and interpret data. Excellent attention to detail
- Ability to work under pressure in order to meet tight deadlines
- Good interpersonal skills (i.e. team player) Problem solving skills
- Effective time management of multiple tasks, Ability to plan, organise and follow up
- Computer proficiency and computer data entry experience required
Key Duties and Responsibilities:
- Overall management of project activities
- Ensures that case processing and handled the work according to the project Standard Operating Procedures (SOPs)
- Plan and oversee the production of all the educational material and guidelines, printed and website information
- Reviewing all project SOPs and work instructions, guidance documents, guidance templates database improvements, quality management plan, safety monitoring plan
- Ensuring compliance with regulatory reporting requirements
- Ensure the client methodology is followed in case processing and case quality review
- Ensure delivery of cases by adhering to processes and SLAs defined during the KT stage and the steady state
- Review case volume and case quality metrics and suggest changes, if required
- Verify case quality and liaise with Team leaders to improve the quality to implement as per the client recommendations, if required
- Recruiting, hiring, training and manage staff including mentoring, performance management, workload prioritization and coaching/development and training project team.
- Building a project team that can effectively triage case management.
- Managing cases as needed and offering conflict resolution on escalated cases.
- Developing and maintaining policies and procedures for collection, processing and regulatory reporting of project deliverables.
- Reviewing and verifying incident reports for completeness and consistency.
- Reviewing and processing requests for reimbursements.
- Coordination with after-hours services to maintain timely and seamless handling of project deliverables
||Pharma/ Biotech/ Clinical research