Documentation Specialist II
55 Corporate Drive, USNJ8100 Bridgewater, NJ
Serve as an associate responsible for ensuring availability of data required for the generation of PSR reports, and ensuring the distribution and submission tracking activities for PSRs is performed. Actively contribute to the development and implementation of improved PV report processes as appropriate; oversee outsourced activities (eg QC, mentoring etc). Interface with PSR stakeholders to: coordinate outputs from the safety database (AWARE), extract internal sales data, obtain partnership data (SDEA), and regulatory and clinical outputs. Oversee the preparation of the AWARE PSR Package in accordance with internal procedures to meet regulatory requirements. Perform related quality control checks of PVDM tasks.Manage the submission tracking activities for periodic reports to support the timely distribution to all relevant destinations. Supports submission-related activities to EMA for PSUSA process (for CAP and NAP products). Liaison with GRA to ensure delivery of package (coordination of the cover letter and validation of the final package) and signed originals in a timely manner. Ensure tasks and activities are performed according to the Work Instructions, procedures and policies in place. Participate in the writing of quality documents related to PVDM activities.
- Coordinate call of information based on MPT (Master Planning Table) extraction with GRA and any other relevant focal points across GPV, company entities and business partners according to SDEA. Ensure that the reports are run according to the proposed schedule; responsible for tracking when reports should be run so that we can plan resources appropriately.
- Generate the monthly AWARE INN table based on the MPT to request validation and final line listings needed for the completion of PSRs by Periodic Reports Associates (PRAs) and LPCs (Local Pharmacovigilance Contacts). The AWARE appendices package from SSU (Systems Support Unit) is extracted and prepared in accordance with internal procedure to meet regulatory requirements and avoid issues during the publishing process. Upload the final line-listings to DOMASYS for the preparation of PSRs.
- Interface with GRA to ensure that the data needed for the regulatory sections of the PSR are received according to timelines guide. Extract and format IMS for interval and cumulative sales data for PSRs and ad hoc.
- Distribution of PSRs or other types of safety reports:
- Ensures that all PSRs are distributed to the appropriate addressees in a timely manner.
- Ensures that all aggregate safety reports are distributed to external partners according the? SDEA
- Submission of PSUR to EMA. Prepare the submission package with relevant stakeholders and distribute to GRA for electronic submission. Monitor submission dates liaise with GRA; complete the ATT (Affiliate Tracking Table) accordingly. Immediately alert hierarchy in case of high risk of non-compliance
Knowledge and Skills:
- Computer literacy especially in Windows based programs
- Ability to effectively troubleshoot issues
- Ability to prioritize and multitask
- Excellent communication skills
- Strong attention to detail and interpersonal skills within or outside department
Formal Education and Experience Required:
- BA or BS preferred
- 4 - 6 years of Pharma or related experience in document support/coordination activities
- Understanding of technologies involved (specifically Advanced MSWord/MS Excel, and Acrobat)
Kaztronix is an equal opportunity employer and does not discriminate on the basis of race, color, national origin, sex, age, religion, disability, veteran status or any other consideration made unlawful by federal, state or local laws.In addition, all human resource actions in such areas as compensation, employee benefits, transfers, layoffs, training and development are to be administered objectively, without regard to race, color, religion, age, sex, national origin, disability, veteran status or any other consideration made unlawful by federal, state or local laws.