Sr. Manager/AD Medical Safety Scientist
Our client is a well-established, mid-size, pharmaceutical company that is rapidly growing their presence within the neurology and oncology sectors. They have been industry leaders for decades and have been at the forefront of innovative breakthroughs in medicines to help treat and prevent: Breast Cancer, Seizures, Alzheimer's and more. Their patient first philosophy has helped the company grow and attract top tier talent over the years.
We are currently recruiting for a Senior Manager/AD Medical Safety Scientist for their Nutley, NJ location. As the Senior Manager, you will manage and review serious adverse events from clinical databases to ensure completeness of patient data.
- Supervise members of the coding and clinical data review in their designated assignments
- Review and approve CRF designs related to coding and safety related field of the CRF
- Review and approve appropriate codes of reported terms in application systems if needed
- Maintain coding guidelines and conventions/ safety data review guidelines and writing guidelines and narrative writing
- Perform aggregate review of adverse events of special interest and assess discrepancies of study medication and adverse events action taken
- Approve queries by clinical data review group and support clinical summary writing process as needed. Review clinical summaries prior to medical review ensuring accurate data is captured and the description of events are medically acceptable
- Coordinates clinical summaries for regulatory submission
- Participate in the development of standard procedures and related documents as appropriate
- Collaborate with system administrators for issues relating to queries in InForm and Data Operations for listings and narrative templates
- Participate in the development and implementation of department standards and documents as needed.
Skills and Requirements:
- Master degree in medical or sciences field is required.
- Minimum 7 years' experience in Data review
- At least 2 years' experience in Coding
- Experience in Clinical Research /Clinical Safety in Clinical Research desirable
- Familiar with MedDRA and WHODD or other coding dictionary
- Experience with Clinical trial Systems e.g. InForm or review tools like J-review/ I-review/Spot fire or any coding application is desirable
- Experience in supporting Neurology and/or Oncology studies
- Experience in writing narratives for submission and review of CSRs or submission
If you are having difficulty in applying or if you have any questions, please contact Nicole Aganon at (+1) 347-293-1161 or email@example.com.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.