Pharmaceutical Clinical Associates, LLC
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Princeton ,
NJ
SUMMARY
The occupant of this contractor position provides support to the Drug Safety Monitor in gathering information and quality control during the processing of serious and non-serious adverse event (AE) reports regarding Bracco products from post-marketing and clinical trial sources. He/she is also responsible for preparing serious adverse event reports, tracking progress of AE reports, and maintaining compliance with internal and regulatory time schedules and deadlines.
DUTIES AND RESPONSIBILITIES
The Associate Drug Safety Monitor is responsible for:
I. Supporting the drug safety monitor in the collection, review, and quality control of data entered in drug safety database for adverse event reports processed at DSP North America/ROW for company products, both in post-marketing and clinical trials to ensure Good Pharmacovigilance Practice and regulatory compliance.
2. Interacting with health professionals and consumers, and communicating medical/safety information responses verbally or via written correspondence, as guided by the Drug Safety Monitor.
3. Assisting in preparation of Adverse Event Reports for regulatory expedited submission (FDA, TPD, etc.) and internal distribution, when necessary, and assisting with resolution of issues relating to adverse experience data.
4. Prepares adverse event reports from medical records and/or literature articles. Data entry of adverse event reports and maintaining the integrity of drug safety database. Writing narratives, determining adverse events and their labeledness and coding in MedDRA and WHO.
5. Assigning and tracking the distribution of an adverse event report to drug safety monitor for compliance.
6. Assuring that the system for tracking processing, distribution and reporting of AE reports is correctly compiled and consistent in order to monitor compliance with internal and regulatory deadlines.
7. Maintaining Drug Safety’s Adverse Event mailbox.
8. Performing a quality check of adverse event reports from licensing partners and reports entered by colleagues.
9. Provides coverage for the Drug Safety Monitors during vacations or absences.
SECONDARY RESPONSIBILITIES
1. Assisting with SAE reconciliation.
2. Interacting with other BDI and BMI staff, and perform other duties as needed.
3. Assisting in generation and maintenance of standard SOPs and working guides.
4. Performing corporate drug safety functions as assigned by the Senior Manager of Drug Safety.
CORE COMPETENCIES
· Excellent oral and written English communications skills.
· Knowledge of regional and international regulations pertaining to pre-marketing and post-marketing safety and surveillance.
· Possess knowledge of medical terminology.
· Proficiency in Clintrace 4.1 and MedDRA.
· Demonstrated cooperation and team work skills.
· High level of precision and accuracy.
Experience and Skills:
EDUCATION and/or EXPERIENCE REQUIRED
Degree in life sciences; pharmacy or nursing licensure is preferred.. Knowledge of ClinTrace 4.1
A minimum of 2 years clinical working experience as a nurse or pharmacist.
A minimum of 1-2 years Drug Safety experience in clinical or pharmacovigilance department, in a pharmaceutical, biotech, or CRO company.
Additional Information:
Job Level: Mid Career (2+ years)
Number of Openings: 1
Years of Experience: At least 2 Years
Level of Education: BA/BS
Salary: TBD
Starting Date : TBD
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Pharmaceutical Clinical Associates is always accepting employment inquiries from professionals interested in our opportunites. If you are interested in career opportunities at Pharmaceutical Clinical Associates please use our online resume formto apply. Pharmaceutical Clinical Associates is an Equal Opportunity Employer.
Princeton , NJ
Princeton , New Jersey
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