Safety Data Management Specialist
Be part of a company that delivers life-changing healthcare solutions. Eclaro is looking for a Safety Data Management Specialist for our client in Peapack, NJ.
Eclaro’s client is among the world’s largest pharmaceutical companies, trusted by billions to provide superior, cutting-edge, and inexpensive medicine that improves health and well-being. If you’re up to the challenge, then take a chance at this rewarding opportunity!
- Review, preparation, and completion of reports of adverse drug experiences, to determine the safety profile of Pharmaceutical’s products and to meet regulatory requirements. Determination of local submission of indifidual and, where appropriate, aggregate safety reports
- Carry out case processing activities
- Review, rank, verify, process and document case-related information: eent terms; validity, seriousness, special scenarios; timelines; accuracy and consistency.
- Process cases based on these assessments
- Review case criteria to determine appropriate workflow for case processing
- Assess case to distinguish those with particular complexities and/or specific issues, and escalate appropriately
- Write and edit case narrative
- Determine and perform appropriate case follow-up, including generation of follow-up requests
- Review processed cases to verify accuracy, consistency and compliance with process requirements, and review case data for special scenarios
- Liaise with key partners, locally, and other stakeholders regarding safety data collection and data reconciliation
- Develop and maintain expertise and knowledge for applicable corporate and global regulations, for guidelines, Standard Operating Procedures, for data entry conventions, and for search functions in the safety database
- Determine reportability of scheduled reports, ensuring adherence to regulatory requirements
- Consistently apply regulatory requirements and Pharmaceutical policies
- Participate, as appropriate, in local, internal and external safety activities
- Reports to Country Safety Lead or Safety Team Lead or Safety Officer (depending on local organization and safety group size)
If hired, you will enjoy the following Eclaro Benefits:
- Experience in pharmacovigilance and/or data management
- Experience and skill with medical writing an advantage
- Demonstrated computer literacy
- Experience in use and management of relational databases
- 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.