Drug Safety Specialist
Our direct end client is looking to bring on board a Drug Safety Specialist on a temporary assignment. Candidate will be responsible for processing serious adverse event reports received from our clients clinical trials in compliance with standard operating procedures, FDA and ICH guidelines and regulations. Generate and submit ICSRs to regulatory agencies. Assist in generating/authoring periodic reports (eg, DSURs, biannual listings, etc.). Develops guidelines and insures uniform and timely processing of adverse event reports. Liaise between clients Drug Safety and other functional groups, as well as associated vendors to develop programs and processes to meet regulatory reporting requirements. Assists in the preparation of safety updates for various customers. Assist in developing and/or updating various forms as appropriate for ongoing and new clinical trials. May work with data management in the ongoing development of case report forms for clinical trials and maintenance of databases.
- A minimum of two years experience in Drug safety or Pharmacovigilance, with hands-on experience in serious adverse event management in clinical trials is required.
- Experience in oncology therapeutic area is preferred.
- Familiarity with MedDRA required.
- Ability to process data entry accurately.
- Ability to code and map data accurately.
- Concise case narrative (medical) writing experience preferred.
- Ability to independently prioritize multiple tasks.
- Written and verbal communication skills are essential.
- Focused and detail oriented.
- Works effectively as a team member, promote collaboration.
- Self starter and accountable.
- Relevant industry experience is highly preferred.
A Bachelors degree in a scientific discipline is required. RN or BSN degree is highly desired. Equivalent experience may be accepted.
BioPoint Inc - 2 years ago
BioPoint, Inc. is a leading global strategic consulting firm that combines deep life sciences industry knowledge with...