Drug Safety Associate
We are currently searching for a skilled professional to join a well-known client’s team as Drug Safety Associate in Stamford, Connecticut. The Drug Safety Associate role will be responsible for monitoring and tracking a variety of safety reports and submissions within Clinical Safety and Pharmacovigilance. As they partner with and support the Drug Safety Functional Team, their work will have a direct impact on not just the organization but the larger clinical industry making this an amazing career opportunity!
- Book-in and perform case processing of serious ICSRs and other qualified case reports in the safety database
- Manage and track receipt of initial and follow-up reports from study sites
- Oversee and ensure compliance with Pharmacovigilance agreements
- Monitor and track reports in the safety desk
- Support aggregate report preparation activities
- Apply case processing and archiving policies and practices per company SOP
- Manage and track report submission and distribution
- Participate and support other functional unit activities as assigned
- Coordinate activities of Drug Safety Functional Unit
- Support and participate in inspection preparedness activities
- Minimum 3-5 years of relevant Safety Database case-processing experience, preferably Oracle Argus
- Knowledge of relevant FDA/GCP/ICH guidelines and AE reporting requirements
- Experience in managing receipt and follow up of SAE reports from clinical sites
- Experience with MedDRA and WHODrug coding dictionaries
- Basic understanding of clinical trial operations and medical terminologies
- Proficient in the use of Adobe Acrobat (Reader and Writer), Microsoft Excel, and Microsoft Word
- Bachelor’s Degree required, preferably in nursing, pharmacy, or a health/science field
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.