Since 1858, Dohmen has been driven by the desire to get safe and effective treatments and cures to the people that need them most. As entrepreneurs, we’ve looked for new and better ways of doing this year after year. Today, as Dohmen Life Science Services, we bring the industry’s most comprehensive service array to Medical Device, Biotech and Pharmaceutical entrepreneurs, helping them get farther faster and keeping them focused on innovations that improve lives.
Our behavior is guided by five simple values –
Caring: We are empathetic and respectful. We ask “how can I help you”
Committed: We are dedicated and persistent. We ask “how can I make it happen”
Creative: We are inventive and imaginative. We ask “how can I do it better”
Collaborative: We are cooperative and share our knowledge. We ask “how can we achieve success”
Courageous: We’re willing to risk failure over inaction. We ask “how can I challenge myself”
This perspective defines us. How we act, how we do business, how we work with our clients and how we work with each other. They are the essence of what makes us successful. They are what set us apart.
The most important aspect of this position is the support of the client Drug Safety Department as both a team member and individual contributor in the processing and analyses of safety data from clinical trials and spontaneous post-marketing reports.
POSITION SUCCESS FACTORS:
- This individual needs to be credible with both internal and external audiences and have unquestioned authority.
- Gives high priority to client satisfaction
- Appreciates the importance of this position toward mentorship and guidance of both staff and clients.
- Works closely with the Drug Safety Management and/or assigned Project Lead to facilitate and meet client project deadlines.
- Provides support to other Drug Safety Associate staff to efficiently manage workload and ensuring
- Timely reporting to Regulatory Authorities and to others as required.
- In addition to case management projects, this individual may also participate in the development of other Dohmen Safety and client documents such as aggregate reports, safety management plans, standard operating procedures, and work instructions.
- Participation in and oversight of Dohmen Safety client case processing activities.
- Collection of Adverse Events (AEs) from all sources, tracking of cases through case processing activities, and coordinating workflow activities to promote accurate reporting and efficient time management.
- Independently assess expectedness, seriousness, and causality in accordance with regulatory guidelines and product reference safety information.
- Independently code adverse events in MedDRA using clinical judgment and medications to WHODRUG.
- Perform a Quality Control check for completeness, accuracy, and consistency of information in the safety database and on regulatory reporting forms (e.g., MedWatch, CIOMS I).
- Independently create a draft narrative of the event(s) based on the description of the case provided by the reporter using a standard narrative construction guide; apply basic rules of grammar to improve the narrative content. Use judgment to decide what information should be included in the narrative to adequately and concisely describe the nature and course of the event.
- Independently formulate follow-up information requests.
- May perform active follow-up via telephone contact with consumers and health care professionals.
- May work with client Clinical Research, sometimes in a lead capacity, regarding information exchange and safety exchange agreements.
- Ensure regulatory compliance with timelines for individual expedited case report submissions and provide assistance and timely delivery of information for aggregate reports, ad hoc report compilations, and other regulatory documents as requested.
- Interact with the client and/or other stakeholders for the purpose of safety data collection, data reconciliation, etc.
- Develop expertise on all assigned client products within a therapeutic area.
- Understand applicable corporate and global regulations, guidelines, SOPs, and writing practices.
- Lead team members, e.g., Drug Safety Coordinators, Drug Safety Associates, to facilitate efficient case processing.
- Conduct periodic reconciliation of SAEs between drug safety and clinical trial databases for ongoing clinical studies with little or no supervision.
- All other duties as assigned.
MINIMUM KNOWLEDGE, SKILLS AND ABILITIES REQUIRED:
The requirements listed below are representative of the knowledge, skill and/or ability required.
- BS degree in a life science discipline (e.g., pharmacy, nursing) is preferred
- 1-3 years of relevant experience, which includes 1 year in drug safety.
- Broad knowledge of domestic and international drug safety regulations, industry practices and standards
- Strong attention to detail, teamwork and initiative
- Strong understanding of drug development, drug safety reporting, as well as an appreciation for the importance of regulatory compliance
- Excellent working knowledge of MedDRA and WHODRUG coding dictionaries
- Familiarity with FDA and international adverse event reporting regulations per ICH guidelines.
- Understanding of medical terminology and familiarity with principles of adverse event reporting in the pharmaceutical industry is a plus.
- Must be quality oriented and demonstrate consistent attention to detail.
- Must have the ability to follow established processes and the flexibility to adopt new practices and priorities as required.
- Must have good planning and organizational skills
- Knowledge of relevant software including safety database and Microsoft Office
- Positive Attitude and Energy – Exhibits an upbeat attitude, a genuine interest in others and a sense of humor. Energizes others and heightens morale through her/his attitude.
- Communication Skills – Possesses the ability to develop and articulate ideas and information that generate understanding and creates a climate that motivates and encourages others to participate.
- Innovator – Transforms creative ideas into original solutions that positively impact the company’s performance.
- Highly Principled – Proves to be a professional of unquestionable integrity, credibility and character who demonstrates high moral and ethical behavior.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.