Drug Safety Associate

Fremont, CA

Contract

apply now

OVERVIEW

We are currently searching for a skilled professional to join a well-known client’s team as Drug Safety Associate to provide support to 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. 

RESPONSIBILITIES

  • Responsible for triage and case intake  
  • Responsible for case processing, narrative creation, and data import from clinical database and reconciliation of case data
  • Interact with Pharmacovigilance, the Medical Monitor, Clinical Operations, Data Management and CROs to ensure safety data is captured and reported correctly and in a timely manner
  • May be asked to participate in special projects such as User Acceptance Testing of safety or clinical databases or the safety gateway
  • Assist with meeting and support activity involving vendors and CROs 
  • Will handle Pharmacovigilance support and administrative projects as assigned

EXPERIENCE

  • Minimum 5 years’ experience in Drug Safety
  • Experience with Safety databases; ArisG and Rave/Medidata preferred
  • Intermediate to advanced computer skills  
  • Must be proficient in Microsoft Outlook, Word, and Excel
  • Excellent written and oral communication skills, the ability to work independently and/or cooperatively with other team members
  • Must be flexible, have strong organizational skills, and the ability to handle multiple priorities
  • Good interpersonal skills
  • Good problem solving skills and the ability to make suggestions to improve efficiencies

EDUCATION

  • Bachelors’ Degree in Life Sciences or related field or equivalent 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.

Google Ads

847-267-1176

Google Tags Manager Footer