CAC India : Pharma Operations
||General Manager (Operations)/ President
||Manage all the operations and deliver high quality of work in field of business processing for the data received from worldwide of clinical projects
||As per company policy. Some overtime as required
||Possibly ~10% 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
- 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
||Pharma/ Biotech/ Clinical research