Drug Safety Specialist
Our client is revolutionizing the medical device industry and is looking to hire a highly skilled professional for the role of Drug Safety Specialist based in Cambridge, Massachusetts. Due to the diversity and number of clinical trials, this position is especially important. The company has a strong reputation in the clinical business to add to your career and resume.
- Responsible for the collection, data entry, routing, follow-up, and timely reporting/submission of safety information
- Handle expedited and aggregate reports
- Responsible for reporting from variety of sources (clinical trial, spontaneous, literature)
- Ensure compliance with SOPs, US regulations, and international regulation
- Prepare for and respond to periodic FDA audits to ensure integrity of AE processing, thoroughness of documentation, accuracy of results, and timeliness of reports
- Responsible for self-initiated quality review within each distinct process step
- 12+ years of experience
- BS or BA in Biological sciences, Pharmacy, Nursing, Life Sciences, Chemistry, or related fields
- Healthcare professional degrees (e.g. RN, BSN, RPH) plus 2 additional years of safety experience
- MS or MA plus 3 additional years of relevant experience
- PharmD 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.