CAC India : Pharma Operations

Position Description


Position Details:

Title  : Project Manager
Reporting to  : General Manager (Operations)/ President 
Company Location  : Mumbai /Pune 
Core Responsibilities  : Manage all the operations and deliver high quality of work in field of business processing for the data received from worldwide of clinical 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  :
  • Master’s degree required or Ph.D , or University degree in pharmaceutical sciences or other relevant medical or scientific disciplines
  • 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 8 years leadership experience 
  • More than 7-8 years of people management  

 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:

  • Ensure operations and complete management for all the project activities.
  • Ensures that processing and handled data according to what is described in the project latest Standard Operating Procedures (SOPs)
  • Plan and oversee the production of operations educational material and guidelines, printed and website information 
  • Reviewing all project specific 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 
  • Recruiting, hiring, training and manage staff including mentoring, performance management, workload prioritization and coaching/development and training pharmacovigilance technicians. 
  • Building a project team and manage effectively. 
  • Managing cases as needed and offering conflict resolution on escalated cases. 
  • Developing and maintaining policies and procedures for collection, processing and regulatory reporting of adverse events. 
  • Reviewing and processing requests for reimbursements.
  • Coordination with after-hours services to maintain timely and seamless handling of cases. 
  • Supporting the needs of the key external stakeholders, such as Regulatory, Marketing, and Executive Management, Opinion Leaders and Partners 
  • Actively promote staff empowerment and accountability 
  • Management daily project operations, including operational and compliance aspects, personnel development/training needs, processes and systems. 
  • Participation in and consultation on preparation and presentation of proposals 
  • Management of contracted services within the area of responsibility on a project basis regarding quality, timelines, costs, etc., in alignment with the operational project management 
  • Writing and publishing as appropriate, safety studies in peer-reviewed journals and assisting with writing technical materials 

 Additional Information:

Industry type  : Pharma/ Biotech/ Clinical research 
Functional Area  : Life science