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.
Key Responsibilities:
- 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
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