CAC India : Pharma Operations
Position Description
Position Details:
| Title |
: |
Deputy Project Manager |
| Reporting to |
: |
Project Manager (Operations) |
| Company Location |
: |
Mumbai/Pune |
| Core Responsibilities |
: |
Coordinate processing of project data received from worldwide and manage operations to deliver high quality of work in field of business processing across all the projects |
| Working Hours |
: |
As per company policy. Some overtime as required |
| Travel |
: |
Possibly ~10% required |
Key Result Areas:
| Pharmacovigilance |
: |
Reporting adverse events in compliance with regulatory requirements and company SOPs whenever necessary |
| Clinical Data Management |
: |
Manage the data interpretations and queries |
| Medical coding |
: |
ICD-9-CM, ICD-10-CM/PCS, and CPT coding; billing and regulatory compliance, healthcare reimbursement methodologies |
Qualifications:
| Required Education and Experience |
: |
- Bachelor of Science degree or Master’s degree required
- Ph.D , or University degree in pharmaceutical sciences or other relevant medical or scientific disciplines preferred
- Minimum of 6-7 years drug safety experience
- Physician Assistant or related healthcare experience
- Pharmaceutical industry experience preferred; Drug Safety case processing experience highly desirable
- More than 3 years leadership experience
- More than 3 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:
- Lead all the projects and represent all project meetings
- Customize the development of project documents
- Develop and maintain a working knowledge of assigned projects
- Develop and maintain a safety events tracking system, process adverse event reports
- Lead all the users to enter the safety information into the safety database and develop a medically precise and brief narrative
- Ensures that processing case volume and handled the work according to the project Standard Operating Procedures (SOPs)
- Plan and oversee the production of project specific educational material and guidelines, printed and website information
- Participate in the process of developing and review of SOPs
- 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 Service Level Agreements (SLAs) defined during the Knowledge Transfer stage and the steady state
- Verify case quality and liaise with Team leaders to improve the quality to implement as per the client recommendations, if required
- Manage staff including mentoring, performance management, workload prioritization and coaching/development and training pharmacovigilance technicians
- Coordination with after-hours services to maintain timely and seamless handling of cases.
- Participate Global Safety process improvement initiatives
|
Other responsibilities:
- Responsible for the championing of process enhancements to the team and to senior management, functional and business leaders
- Identifies business development opportunities and communicates them to the senior management
- Manages Service Improvement Programmes within the Delivery operations
- Responsible for functional Operations staff and for maintaining headcount to the agreed plan
- Recognized as having expert knowledge and vision in Client Delivery Operation
|
Additional Information:
| Industry type |
: |
Pharma/ Biotech/ Clinical research |
| Functional Area |
: |
Life science |