Drug Safety Associate
Be part of a company that delivers life-changing healthcare solutions. Eclaro is looking for a Safety Associate for our client in Pennington, NJ.
Eclaro’s client is a leader in the Biopharmaceutical Industry, providing quality, innovative, and affordable medicines that make a difference in the lives of patients all over the world. If you’re up to the challenge, then take a chance at this rewarding opportunity!
The Safety Associate position will lead subject matter expert in prioritizing cases and entering critical data in order to meet regulatory reporting responsibilities.
- Accountable for incoming reports and information contained therein to determine the seriousness of the report, determine contractual responsibilities in order to assign a regulatory due date.
- Accountable for identification of all related clinical study cases for Semi-annual report of Suspected Unexpected Serious Adverse Reaction (SUSAR)
- Accountable for identification of potential signal detection cases and communicates this to the Medical Review Safety Physician (MRSP).
- Organizes work load in order to prioritize the most urgent deliverables (i.e. reports) ultimately to execute accurate reportable timelines
- Utilizes knowledge of specific work practices, Safety Data Exchange Agreement (SDEA), Standard Operating Procedures (SOP), and regulations in order to process cases in a timely manner and lead the team to execute the process appropriately.
- Seeks to understand and adhere to SDEA in processing cases involving products under co-marketing arrangements in order to handle all cases in a timely manner. Serves as a resource to identify Client products and designated co-marketers.
- Incorporates medical and fundamental complex understanding of the human anatomy and its functions in order to process adverse event reports in an accurate and consistent manner.
- Oversees that all follow up cases go into the appropriate case based on ICSR and also liaises with MRSP if needed.
- Develop and execute training for allignment in processing.
- Accountable for multiple tasks, prioritizes tasks according to designated criteria and remains flexible as processes and priorities change.
- Exercises a high degree of adaptability in dealing with an ambiguous and complex work environment, which includes demands not only from respective teams, but also from regulatory agencies, co-marketing partners and the GPV&E Medical staff.
- Serves as a trainer, mentor, and guide for colleagues within GPV&E through providing perspective on the broad organizational impact on their daily work.
- Coordinates the daily responsibilities and workload of the team by deploying resources and delegating appropriately and equitably in order to meet short term and long term goals defined for adverse event processing.
- Work directly with Sr. Triage Associate to get core daily work responsibilities completed. Sr. Triage Associate directs the team to prioritize cases and special projects and delegates when needed.
- Degree/Certification/Licensure Bachelor's degree, scientific/medical background (B.S./B.A, M.S.) in Life Science, Nursing, Regulatory Affairs, Chemistry or Pharmacy
- RN or PharmD
- Pharmaceutical experience with a strong preference in pharmacovigilance, drug development, clinical development, quality and/or regulatory.
- Mastery of health / life sciences gained through either formal education or on job experiences.
- Mastery of AE processing both internally and externally, as well as the ability to understand the future impact.
- Mastery of the intricacies of AWARE (the Client drug safety database) or other related safety database.
- Knowledge of Client drug development and commercialization process and the impact of AE Processing on that process.
- Knowledge of general safety reporting requirements, regulations, guidelines and procedures.
- Experience working with a wide range of technically and culturally diverse people and influencing them to accomplish a common goal.
- Experience utilizing problem solving techniques to ensure that AE reports are available for processing at the earliest possible time.
- Experience supervising a team.
- Experience communicating to a diverse audience, at multiple levels through various formats (i.e. presentations, meetings, proposals, face-to-face meeting).
- First hand experience working directly with customers, technical experts and professional staff.
- Software that must be used independently and without assistance (e.g., Microsoft Suite)
- Department: Case Creation/Triage'
If hired, you will enjoy the following Eclaro Benefits:
- 401k Retirement Savings Plan administered by Merrill Lynch
- TransitChek Pretax Commuter Benefits
- Eligibility to purchase Medical, Dental & Vision Insurance through Eclaro
Interested in applying?
Contact Cheryl Buot at CherylB@eclaro.com now.
Equal Opportunity Employer: Eclaro values diversity and does not discriminate based on Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.