Drug Safety Associate
At Advanced Clinical, we’re excited to share with you a great opportunity at a growing organization committed to clinical excellence for the position of Drug Safety Associate. The Drug Safety Associate is located in Princeton, New Jersey, and will be committed to performing and overseeing various aspects of the ICSR process as assigned by the management in the Pharmacovigilance Department. Their work will have a direct impact on not just the organization but the larger clinical industry making this an amazing career opportunity!
- Create study documents, including materials for regularly scheduled meetings with the client
- Performing quality checks using applicable browser and reporting tools
- Participate in client study kick-off and close-out meetings
- Prepare study set-up, review documents (CRFs, DMP, DCP), perform user acceptance testing on the database, and edit checks
- Perform DM Review, utilizing the DMP and DCP
- Perform vendor data reconciliation with applicable clinical database
- Issue queries and track all DM issues to ensure proper resolution by study completion
- Identify data trends and inconsistencies, and develop a corresponding plan of action
- Communicate with client representatives and the programming team regarding database and programming needs or issues throughout the study
- Assist with final QC reviews and data listing audits
- Perform database freeze/lock and coordinate all related activities
- Perform first and second pass entry following the DMP and client conventions
- Create and review SOPs and training materials
- Minimum 2-3 years experience in Pharmacovigilance required
- Extensive knowledge and experience with ICH guidance, as well as FDA and EU regulations and requirements for Pharmacovigilance
- Experience in ensuring quality and accuracy of clinical study database
- Experience with the first and second pass entry of Case Report Forms (CRFs), Data Clarification Forms (DCFs), Quality Control (QC) checks, and Data Management Review (DM Review)
- Bachelor’s Degree required (preferably in biology, pharmacy, or other related field) OR Healthcare Professional Degree (e.g. RN, BSN, RPH) plus 2 years of Safety experience required
- Master’s Degree required OR Pharm.D, plus 1-2 years of relevant experience (a 1 year residency or fellowship may be considered relevant experience)
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.