We are currently searching for a skilled professional to join a well-known client's team as a Case Processing Associate in Princeton, New Jersey. The Case Processing Associate role will work with management to help facilitate day-to-day oversight, review, and evaluation of the vendor performance and quality. Their work will have a direct impact on the organization and the larger clinical industry, making this an amazing career opportunity.
RESPONSIBILITIES
Process incoming adverse events information, conduct adequate follow-up, and adhere to strict GCP guidelines/regulatory reporting regulations
Identify and communicate data entry issues to Good Pharmacovigilance (GPV) management in a timely manner
Collaborate with Medical Affairs, Commercial, or Marketing to develop processes, forms, and/or training to support Patient Support Programs, Market Research, and Investigator Initiated Studies
Contribute to safety requests from Regulatory Authorities
Participate in the development and maintenance of PV System policies, SOP forms, and guidance documents to ensure compliance with all applicable regulatory requirements or guidelines, GVP, and industry best practices
Maintain up-to-date knowledge of protocol and scope of work for assigned projects
Provide process improvement suggestions
Ensure the safety database is maintained as necessary to track documentation
Attend clinical meetings
Review protocols, SMPs, PVAs, and SOWs
Assist with database lock
Interact with Contract Resource Organizations
Support department and functional area projects
EXPERIENCE
Minimum of 2 years of pharmacovigilance experience required
Experience and demonstrated understanding of global safety reporting regulations and guidelines including the FDA, ICH, and EU Regulations and Requirements for Pharmacovigilance required
Knowledge of the ARGUS Safety Database
Demonstrated experience in case processing
Knowledge of the inner workings of Global Pharmacovigilance organization desired
Experience with managing vendors, partners, and/or CRO's preferred
Excellent technical skills, including the ability to comprehend and integrate scientific data from a variety of sources
Strong communication and writing skills
Proficient in the Microsoft suite of programs (Word, Excel, PowerPoint, and Outlook)
Ability to manage multiple tasks simultaneously and prioritize competing requests or projects
Strong attention to detail along with the ability to problem solve
Excellent project management skills with the ability to align internal and external resources
EDUCATION
Minimum of Bachelor's Degree in a scientific field required, in the health sciences area (e.g., Nursing, Pharmacy) preferred
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.
It is Advanced Group's practice not to discriminate against any employee or applicant because of sex, race, color, age, national origin, religion, gender, gender identity/expression, sexual orientation/sexual preference, pregnancy/maternity, genetic information, marital status, physical/mental disability, medical condition, military/veteran status, or any other basis protected by applicable federal, state, or local law. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter so that we can discuss the appropriate alternatives available.
