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  


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