Sr. Project Specialist, Aggregate Safety Reporting

Summit, NJ
Oct 14, 2017
Required Education
Bachelors Degree
Position Type
Full time

Other Locations:US- NJ- Summit West

Reporting to the Senior Director   Global Drug Safety & Risk Management, Aggregate Safety Reporting,  the Sr. Project Specialist facilitates Aggregate Safety Report (ASR) production activities across GDSRM including PSURs, DSURs, US PSRs, Addendum reports, Renewal reports, and other reports as required.

Responsibilities include, but are not limited to, the following:

  • Creating and maintaining the ASR project schedules

  • Ensuring all contributors are maintaining compliance with time lines

  • Tracking ASRs and their due dates

  • Plan, schedule, coordinate and lead kick-off, strategy and comment resolution meetings

  • Plan, schedule and coordinate resources (people and time) needed for ASR creation

  • Identify all personnel involved in ASR preparation prior to kick-off meeting

  • Lead ongoing ASR production meetings

  • Solicit information for ASRs  from identified contributors via email

  • Create workflows (review and approval) for each of the ASRs in the document management system

  • Liaising with PV/EPI group supporting approved products and activities

  • Liaising with TSS group supporting development products and activities

  • Liaising with Regulatory Affairs to coordinate contributions for and synchronization of periodic reports

  • Liaising with other contributing groups as appropriate

  • Schedule additional meetings as needed to resolve issues

  • Collaborate on the drafting of key SOPs & WPs related to ASR processes

  • Perform other activities as needs arise in the context of ASRs

  • Representing ASR and collaborating with business partners to promote streamlined processes

Skills/Knowledge Required:

  • Education:  BA, BS, MA or MS in Business, Computer Science, Health Science  or related discipline

  • Certification: PMP certification is desirable

  • Experience:  Five (5) years relevant experience in pharma/biotech, preferably in PV; Three (3) years relevant experience in project planning desirable

  • Excellent skills and proficiency with Microsoft Office products: Word, Outlook, Project, Excel, PowerPoint required;  Visio and Livelink (or similar document management platform) desirable

  • Experience with safety databases (ARISg or similar)

  • Experience with document management systems and/or electronic shared work spaces, e.g., SharePoint

  • Ability to identify existing or potential deficiencies in procedures, and recommend solutions

  • Strong communication skills (both oral and written) and the ability to interact with various levels, both within GDSRM as well as other parts of the organization

  • Knowledge of US, EU and ROW PV regulations

  • Demonstrated ability to work independently with effective presentation and interpersonal skills to ensure a team-oriented approach  

  • Ability to demonstrate a familiarity with principles of PV

  • Ability to work as part of a team, multi-task and meet internal and regulatory deadlines

  • Familiarity with safety database outputs, preferably ARISg and reporting tools, eg Business Objects