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location: Cambridge, Massachusetts
job type: Contract
salary: $101.19 - 119.05 per hour
work hours: 9 to 5
- Medical Review: Provides medical review of individual and selected serious and non-serious reports of adverse events from a variety of sources. Provides medical review, performs causality, listedness and seriousness assessment, and determines regulatory reportability of clinical trial cases for assigned products and across therapeutic areas.
- Compliance: Ensures complete and timely medical review to ensure accurate and compliant reporting of ICSRs to regulatory authorities globally within regulatory time frames. Collaborate with "Quality" and safety operations teams to ensure consistency of work practices and SOPs. Demonstrated ability to apply Client operating philosophy and operate within company policies and procedures and appropriate regulations.
- Collaboration: Partner with other GDS personnel from other functions (AE processors, safety scientists and Global Safety Leads) in evaluating the safety profile of Shire products. Identifies potential safety signals and informs the appropriate GSL of all potentially important cases and issues.
- Must be able and willing to participate in mentoring and training of new and or junior colleagues and work with the Head of Medical Safety Review to implement and augment onboarding and training processes.
- Development/Processes: Addresses safety-related issues using good medical judgement and regulatory analytical strategies to develop optimal solutions. Works closely with colleagues in safety operations & Drug Safety Surveillance to identify and implement new and more efficient processes for safety reporting and risk assessment.
- Is an active, high energy proponent of the company's commitment to patient safety and the integrity of our products. Influences and impacts others through clear reasoned arguments based on good medical knowledge and judgement, to meet product needs and regulatory objectives.
- Represents DSS in ICSR medical review with competence and integrity. Ensures that the above tasks are performed efficiently with high quality, good clinical and pharmacovigilance judgement, data accuracy, and in accordance with GDS' SOPs, and GDS quality & compliance goals.
- MD or Equivalent with post graduate clinical training, and at least 2 years of clinical practice experience.
- Medical Degree with primary care or speciality certification preferred.
- Minimum 2-4 years in clinical practice
- Minimum 2 years experience in pharmaceutical industry
- Knowledgeable and skilled in medicine and pharmaceutical product safety.
- Experience applying medical knowledge to the interpretation of individual case review.
- Experience with identification of coding and assessment of individual adverse events in ICSRs.
- Experience working in a team environment, including supporting other team members when necessary; promote collegiality and teamwork among peers.
- Ability think clearly and decisively and present independent, reasoned solutions to identified safety issues,.
- Demonstrated creative problem solving skills that enact change and drive continuous improvement.
- Seeks to develop self and others.
- Aligns objectives with organizational goal.
- Proficiency in English with Excellent oral and written skills.
- Excellent communication, interpersonal and time management skills
- Demonstrated flexibility, open mindedness and adaptability in a rapidly changing environment.
- Ability to build and manage inter-relationships by motivating and inspiring others.
- Ability to operate with minimal direction, but knows when to ask questions
- Experience in Argus safety database is preferred.
skills: SOP, Argus, ICSR (Individual Case Study Report)
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.