The Director Case Processing and Submission is responsible for providing direction and oversight for all individual case safety report (ICSR) processing and submission activities of post-marketing cases, ensuring that reportable adverse events are identified and processed in accordance with global regulatory requirements. This incumbent will manage global case processing vendors ensuring high quality and compliance.
Ā
Key Responsibilities:
Ā
- Oversee and manage the processing, review and submission of all individual case safety reports to ensure high quality and compliance.
- Oversee and manage the global literature search.
- Manage and develop Global team.
- Coordinate with external vendor and internal medical personnel as needed.
- Provides oversight and support for external safety data processing provider, ensuring efficient and cost-effective services.
- Coordinates product safety oversight activities.
- Assist team and senior management in all forms of safety issue management and mitigation.
- Analyze metrics for critical department processes to ensure compliance with SOPs and regulatory requirements.
- Formulate and implement improvements and enhancements as needed, including procedural and technical advancements.
- Represent GPRM in key internal departments interactions including Regulatory Affairs, Clinical R&D, Quality Assurance and Medical Communications.
- Inform Risk Management department when aware of any safety-related issues and potential trends and/or signals arising from review of post-marketed safety data.
- Manage PV CAPA related to case processing, submission and literature search. Support integration activities related to acquisitions, mergers and divestments of products.
- Answer questions from authorities related to vigilance
- Participate in audits and inspections.
- Ensure business continuity of processes.
- Maintain current knowledge of global pharmacovigilance regulations and requirements.
Other:
- Must understand and apply all company SOPs, policies and procedures
- Take care of a good company reputation within his/her positive attitude
- Undertakes to comply with the regulatory requirements
applicable to the pharmaceutical activities that he/she works on
- Back-up for Director of Clinical Safety and Reconciliation
Ā
Ā
Knowledge/Skills: Global safety and pharmacovigilance regulations and guidelines; Use of safety database, preferablyARISg; Working knowledge of scientific terms and medical terminology including proficiency with MedDRA and WHODrug use and administration;
Excellent oral and written communication skills; Excellent interpersonal skills and willingness to work in a team environment;
Ability to utilize and develop available human and technical resources; Demonstrates consistent attention to detail; Highly organized and demonstrates understanding of workflow prioritization and resource allocation.
Education: BS/MS/Doctorate degree in Pharmacy or Nursing, or related discipline or comparable field of study from an accredited college or university.
Experience: Minimum 7 years in the pharmaceutical industry with at least 5 years in drug safety/pharmacovigilance, 2 of which must be in a management position with direct report