Highlights
Position will also be responsible for managing aggregate reporting schedules, conducting worldwide regulatory reviews and impact assessments, supporting health authority responses, driving process improvements, and implementing and maintaining PV procedures. Position will mainly be responsible for leading and conducting aggregate reporting projects, including authoring and managing PSURs, DSURs, PADERs, and local safety reports independently or collaboratively.
Numbers & Facts
| Location | Cambridge, MA (Remote) |
| Industry | Staffing/Employment Agencies |
| Salary | $75–$79 Per Hour |
| Company Size | 500 to 999 employees |
| Website | https://www.thefountaingroup.com/ |
Description
We are a national staffing firm and are currently seeking a Drug Safety Consultant II for a prominent client of ours. This position is 100% Remote in the Eastern Time Zone.Details of the position are as follows:
Job Description:
If you are interested in hearing more about the position, please respond to this post with your resume attached
Please forward this email to any friends or colleagues as we do offer a Referral Bonus for any candidate who is hired and still gainfully employed after 30 days.
By applying for this job, you agree to receive calls, AI-generated calls, text messages, or emails from and its affiliates, and contracted partners. Frequency varies for text messages. Message and data rates may apply. Carriers are not liable for delayed or undelivered messages. You can reply STOP to cancel and HELP for help. You can access our privacy policy at Privacy Policy
Job Description:
- Pay: $75.00- 79.00/hr to start.
- 1 year with the possibility of extension or conversion based on budget and performance.
- 100% remote position must be located in Eastern Time Zone.
- Position will mainly be responsible for leading and conducting aggregate reporting projects, including authoring and managing PSURs, DSURs, PADERs, and local safety reports independently or collaboratively.
- Responsibilities also include serving as a subject matter expert on safety requirements, company policies, aggregate reporting processes, regulatory legislation, health authority responses, and cross-functional safety activities.
- Position will also be responsible for managing aggregate reporting schedules, conducting worldwide regulatory reviews and impact assessments, supporting health authority responses, driving process improvements, and implementing and maintaining PV procedures.
- Bachelor's, Masters, or PhD is required.
- Minimum of 5 years of Pharmacovigilance experience, including direct experience in aggregate safety report writing and safety signal management.
- Ability to understand, interpret, analyze, and clearly present scientific and medical data verbally and in writing (including medical concepts and terminology).
- Proven track record of working collaboratively in a team environment across Safety, Clinical Development, Medical Affairs, Clinical Operations, Regulatory, and external colleagues.
- Ability to apply clinical judgment to interpret case information and guide staff on case data evaluation.
- Familiarity with pharmacovigilance, drug development, clinical trial safety regulations, and post-marketing safety regulations (including case processing, expedited reporting, and safety databases).
- Basic knowledge of standard software (Excel, PowerPoint, Word, Business Objects) and familiarity with common safety database systems.
If you are interested in hearing more about the position, please respond to this post with your resume attached
Please forward this email to any friends or colleagues as we do offer a Referral Bonus for any candidate who is hired and still gainfully employed after 30 days.
By applying for this job, you agree to receive calls, AI-generated calls, text messages, or emails from and its affiliates, and contracted partners. Frequency varies for text messages. Message and data rates may apply. Carriers are not liable for delayed or undelivered messages. You can reply STOP to cancel and HELP for help. You can access our privacy policy at Privacy Policy
About Company
The Fountain Group provides Contingent Labor, Statement-of-Work, and Contingent-to-Permanent resources to clients with an internal/external Contingent Labor Managed Service Program or Clients without a program. The Fountain Group is committed to the belief that we all share in the responsibility to conduct our businesses in a socially and environmentally responsible manner. We base this on the premise that a company is much more than the products it offers. The effect a company has on the environment, the people and the communities it serves reflects the company’s dedication to being not only a good business, but to being a good corporate citizen. The Fountain Group believes the key to servicing a client is to identify the client demand precisely. Therefore, The Fountain Group focused its efforts on building and developing a process, which can identify an exact match for our client’s needs. Our process utilizes modern technology combined with 30+ years of Talent Acquisition experience to deliver Precision resources. Financial strength is prominent among The Fountain Group’s corporate values. The future of our business will be built on the innovation, compassion, outstanding services and technology, but a solid financial foundation is required to carry us forward to meet our business goal and support our long term vision.
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