Description
The senior Drug Safety Associate is responsible for overseeing all aspects of adverse event processing and reporting for assigned investigational and marketed products, while also assisting management in establishing and implementing departmental strategy. Serves as a liaison to external healthcare providers, investigational sites, and company personnel for safety-related issues, working in close collaboration with colleagues from Clinical Science, Clinical Operations, Biometrics, Regulatory & QA, MedSA and Commercial.Some responsibiliies are:
- Ensure that all safety reports received from any source (clinical trials and post-Ensure consistency in the initial evaluation and assessment of incoming case reports and source documentation for completeness, accuracy,& legibility
- Exercise judgment and use knowledge of FDA and ICH guidelines and product labeling in performing initial case assessment for seriousness and expectedness / listedness
- Ensure appropriateness of MedDRA and WHO-DD coding performed by Drug Safety staff
- Assist with Quality Control reviews of others' cases to ensure the accuracy, integrity and completeness of information entered into the safety database.
- Liaise with assigned Physicians in Drug Safety, Clinical Science and/or MedSA to ensure that appropriate medical review and assessment is provided for assigned case reports
- Perform follow-up, as needed, either directly with reporter, through Call Center, or through appropriate CRAs, and documents results in case file
- Ensure that required follow-up for assigned cases has been completed
- Communicate with partner companies, collaborative sponsors and their respective clinical research organizations (CROs) regarding the evaluation and processing of case report.
Interested candidates must have:
- Bachelor's level degree in life sciences, pharmacy, nursing or equivalent
- Basic familiarity with pharmaceutical/biotech industry and drug development process.
- Extensive experience with software-based drug safety systems required, preferably ARISg
- Strong computer skills (MS Office)
- 3-5 years of Pharmacovigilance / Drug Safety experience or equivalent required. Both pre-approval and post-marketing experience in a global environment highly desired.
- Expert knowledge of relevant FDA, EU and ICH guidelines, initiatives and regulations governing both clinical trial and post-marketing safety environments
- Working knowledge of the overall drug development process
- Extensive knowledge of medical terminology and principles of clinical assessment of adverse events in the pharmaceutical industry
- Expertise in MedDRA dictionary with relevance to adverse event coding
Any interested candidates please apply ASAP as request of the employer
To find out more about Real please visit www.realstaffing.com