Documentation Specialist II : Global PV Operations (19-00640) – NJ – Bridgewater

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 Client PV report processes as appropriate; oversee outsourced activities (eg QC, mentoring etc).

Coordinate call of information based on MPT (Master Planning Table) extraction with GRA and any other relevant focal points across GPV. 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.

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.

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

BA or BS preferred
4 – 6 years of Pharma or related experience in document support/coordination activities
Understanding of technologies involved (specifically Advanced MSWord/MSExcel, and Acrobat)
Source: Job Diva – Job Listing

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