Penfield Search Partners
Contact: Allie Spink – aspink@penfieldsearch.com
The GPV Submission Specialist tasks include:
- Play an integral role in management of daily operational activities of the Global Submissions Team within Case processing.
- Responsible for managing timely submission of Global ICSRs to various Health Authorities, License Partners and CROs.
- Monitoring of Global submissions mailbox to address all the high priority emails/ queries received from health authorities/ license partners related to ICSR submissions.
- Prepare local paper submissions to US FDA in accordance with company processes
- Responsible to address daily worklist to complete submissions to all applicable reporting destinations
- Generate, Review, and Transmit reports to all Global Health Authorities including but not limited to FDA European Agencies, Health Canada and various other Health Authorities.
- Timely submission of appropriate reports to global partners based on defined timelines as per the PVA.
- Responsible for timely submission of expedited ICSR reports to Ethics Committees and Investigators based on the country requirements.
- Monitoring the safety database for failed transmissions to resolve the issue in a timely manner.
- Involved in preparing safety ICSR submission package to Health Authorities as per the requirements.
- Follow-up with Case Processing team and Medical Reviewers to request appropriate case correction for timely submissions of reports.
- Provide training and support to newer members of the submission team
- Collaborate with Regulatory Intelligence team, Safety Data Management to maintain accurate reporting rules in the Safety Database.
- Review of Pharmacovigilance Agreements and Safety Management Plans to identify new requirements and/or updates for configuration of reporting rules in safety database.
- Responsible for configuring clinical studies in the database, review clinical trial protocols and configure reporting rules as per regulations.
- As Submissions SME, support local safety managers on daily basis for all ICSR submission related matters.
- Identifying root cause for late ICSR submissions and to provide appropriate corrective and preventive actions to Compliance and Business Management team.
- Responsible for timely investigation, analysis, and action on health authority queries.
- Monitor and address weekly ICSR submission reconciliations with local safety managers.
- Assist the Global Pharmacovigilance team with various projects to enhance system performance.
Qualifications/Experience:
- Degree preferred to be in Bachelor of Science or related healthcare degree however may be waived for relevant experience**
- 1 to 3 years Drug Safety experience required*
- Demonstrated proficiency in safety database functionality
- Prior submission experience is required
- *Drug Safety experience is defined as actual experience processing AE/SAE reports, generating narratives, queries, working within safety databases, and experience with regulatory submissions
- **Relevant experience includes experience in the pharmaceutical, biotechnology, or CRO industry, partly in related areas such as Medical Affairs, Clinical Data Entry and Clinical Data Management, Clinical Monitor, Regulatory Affairs, or Quality Assurance
Required Skills Include:
- Must have sufficient experience and a demonstrated knowledge and understanding of global safety reporting regulations and guidelines including the FDA, ICH, & EU Regulations and Requirements for Pharmacovigilance
- Knowledge of the ARGUS Safety Database
- Knowledge and prior experience in case processing
- Knowledge and experience with working on expedited ICSR submissions to Health Authorities
- Knowledge of Medical device submissions
- Knowledge of expedited ICSR submissions to Ethics Committees and Investigators
- Excellent technical skills, including the ability to comprehend and integrate scientific data from a variety of sources.
- Strong communication and writing skills
- Strong computer skills with demonstrated experience in working with the Microsoft suite of programs (Word, Excel, PowerPoint, and Outlook)
- Knows how/when to apply organizational policy or regulatory procedures to a variety of situations. Ability to work under pressure to meet tight timelines
- Able to work effectively in a matrix environment Strong attention to detail along with the ability to problem solving
- Proven ability to work in a team environment
- Proven ability to manage multiple projects simultaneously