Safety Publishing Specialist
At Advanced Clinical, we’re excited to share with you a great opportunity at for the position of Safety Publishing Specialist in Bridgewater, New Jersey. The Safety Publishing Specialist serves as the specialist responsible for ensuring electronically compliant pharmacovigilance (PV) reports. Their work will have a direct impact on not just the organization but the larger clinical industry making this an amazing career opportunity.
- Actively contribute to the development and implementation of improved PV report processes
- Support the review, QC, approval and notification process of reports published in DOMASYS
- Provide DOMASYS and DOMEX and publishing support for all PV reports to include RMP, Adhoc Safety Reports, PSMF publishing
- Act as DMS expert for eCTD, PV report publishing, DOMASYS Template coordination, other report publishing related projects
- Responsible to deliver on time published reports to PSR customers in required format
- Troubleshoot issues raised by DMS, and provide ad hoc user support to GPE collaborators in the use of DMS and advanced features of MS Word
- Participate in the writing and updating of quality documents related to PV Publishing activities
- A minimum of four years of Pharma or related experience in document support and coordination activities
- Understanding of technologies involved (specifically Advanced MS Word, MS Excel, Documentum, Core Dossier, Insight Publisher and Acrobat)
- Working knowledge of ICH guidelines concerning the production and submission of PSURs and of EU Clinical Trial Directives
- Document Management System experience and training
- Bachelor’s Degree required
To be a best-fit your strengths must include
- Strong Communicator. You will have extensive correspondence that relies on you being conversant in regulatory guidelines and clinical terminology.
- Organized. You’re an efficient time-manager and can handle the pressure of meeting multiple strict deadlines.
- Ability to work independently and with a team: You will be collaborating and often contributing to discussions amongst internal teams; you also work effectively without a lot of support or structure.
- Problem-Solvers. As an action-oriented self-starter, you’re eager to apply your expertise in diagnosing inefficiencies, determining root causes, and recommending solutions to complex challenges.
- Personable. You establish and nurture highly effective relationships with colleagues and key stakeholders that support and advance project goals and objectives.
- Credible. Thorough understanding of clinical methodologies and providing sound analytical support, you quickly establish credibility as a reliable resource.
About Advanced Clinical
Advanced Clinical is an award-winning clinical development organization that provides global services including CRO, Functional Support, Quality & Validation, Patient Recruitment and Retention, and Strategic Talent Acquisition solutions for pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations. Our mission is to deliver a truly better clinical experience for our clients and candidates. To learn more about Advanced Clinical which has been named to Chicago Tribune’s Top Workplaces, Chicago’s Best and Brightest Companies, and Best of Staffing Talent & Client, visit http://www.advancedclinical.com.
Regarding your application
Please know that every completed application is carefully reviewed by the Advanced Clinical recruitment team. We understand the time commitment that is needed to prepare an application, so we respect your effort by thoughtfully reviewing and responding to each application. In return, we ask for your patience as careful review takes time, and we may not be able to respond to every application immediately.