Job Summary (Primary function)
This Global Risk Management & Safety Surveillance (GRMSS) Scientist collaborates with the GRMSS Physicians and GRMSS Scientists to characterize the evolving clinical and post-marketing safety profiles for investigational drugs and/or products, based on analysis of aggregate data sets from internal or external sources and the medical literature. This entails drafting, reviewing, and refining portions of periodic aggregate safety reports (including DSURs, PADERs/PAERs, and Risk Management Plans (RMPs)). The GRMSS Scientist performs the signal detection activities and review process for clinical data, including signal detection, evaluation, and verification; potential sources of data for signal detection include Incyte, external marketing partners, or contracted business entities. The GRMSS Scientist in this position documents signal detection activities and communicates appropriate summaries to internal stakeholders and external partners.
Essential Functions of the Job (Key responsibilities)
- Support GRMSS Physicians and GRMSS Scientists and aid in the coordination and preparation of Safety Management Team meetings.
- Provide support as needed to the GRMSS Physicians in review of periodic literature for new and important information regarding products.
- In collaboration with the GRMSS Physicians/Scientists, support the preparation of Development Safety Update Reports (DSURs), Periodic Benefit-Risk Evaluation Reports (PBRERs), Periodic Adverse Drug Experience Reports (PADERs), Periodic Adverse Experience Reports (PAERs), and updates to Risk Management Plans (RMPs) for clinical trial programs and marketed products.
- Participate in internal safety process improvements and updates.
- Contribute to preparedness for regulatory authority inspection and internal audits of Pharmacovigilance by following standard operation procedures and processes.
- Provide overall support to the GRMSS Physicians and GRMSS Scientists for global risk management and safety surveillance activities.
Qualifications (Minimal acceptable level of education, work experience, and competency)
- Healthcare degree (e.g., BSN, CRNP, Pharm.D.) preferred (or relevant scientific degree buttressed by industry experience).
- Two to four years of Pharmacovigilance/Drug Safety experience required.
- Experience analyzing safety case reports for the purpose of preparing aggregate safety reports (DSURs, PADERs, PBRERs), signal detection and evaluation, and responding to queries by regulatory authorities required.
- Experience incorporating safety findings into aggregate reports (DSURs, PADERs/PAERs, PBRERs) required.
- Fluency in written and spoken English.
- Experience in pharmaceutical industry activities involving health authorities in the United States and across Europe.
- Experience in pharmacovigilance relating to oncologic or inflammatory diseases, or relating to clinical support of oncology, immunomodulatory, or other related products preferred.
Kaztronix is an equal opportunity employer and does not discriminate on the basis of race, color, national origin, sex, age, religion, disability, veteran status or any other consideration made unlawful by federal, state or local laws. In addition, all human resource actions in such areas as compensation, employee benefits, transfers, layoffs, training and development are to be administered objectively, without regard to race, color, religion, age, sex, national origin, disability, veteran status or any other consideration made unlawful by federal, state or local laws.
By applying to the position, you acknowledge that your information will be used by Kaztronix in processing your application.
