Identify and assist in the management of safety concerns with the company’s drug product(s). Ensure that any safety signals are appropriately evaluated, communicated and managed with guidance from supervisor. Responsible for writing documents required for assessment & communication of product safety information for core safety documents.
Key Accountabilities/Core Job Responsibilities:
* Perform aggregate safety data tabulation and listing compilation. Able to provide some clinical judgment on safety data review
* Collaborate with safety physicians, medical monitors, toxicology group, and other functional groups in identification, analysis, and reporting of possible trends or concerns
* Contribute to development & maintenance of product safety profile
* Track events of special interest and assist in development & maintenance of standardized queries for events of special interest
* Support the analysis in support of response to regulatory, EC/IRBs and Investigators or ad hoc inquiries regarding safety issues
* Draft regulatory inquiry responses
* Provide input and review to key regulatory or clinical documents (i.e. clinical study reports, investigator brochures, integrated summaries of safety, DSUR); may author certain sections as needed under the supervision of the director
* Perform literature search and review and able to effective determine appropriate and relevant literature for the purpose of safety analysis.
* Participate in internal pharmacovigilance committee meetings as well as joint safety meetings with licensing partners.
Education, Experience and Qualifications:
* MSc, Pharm.D., Ph.D. preferred
* Minimum of 3 years experience with pharmacovigilance or clinical safety
* Previous experience in scientific /medical writing required
* Ability to read and collate scientific and medical literature
* Working knowledge of relevant FDA, EU, ICH guidelines, initiatives and regulations governing both Safety reporting and processing for clinical trial environments
* Working knowledge of MedDRA dictionary
* Familiarity with common Safety databases (e.g. Argus, Aris , etc) is preferred
* Proficient with Windows: MS Word, Excel, Power Point and ability to learn new programs as needed
* Must have excellent writing and communication skills
* Collaborate effectively with the study team, cross-functional team members, and external partners.