PV Scientist

PV Scientist, Contractor, Safety Risk Management 6 Months Remote Summary of Key Responsibilities - Works closely with the safety lead physician to analyze potential safety issues, including signal detection, signal evaluation and signal management. - Collaborates proactively with study teams, cross-functional team members, external business partners and vendors to apply knowledge and analytical skills to problems in specific therapeutic areas. - Contribute to signaling and data mining activities utilizing internal and external sources of data. - Performs signaling data review from all sources including but not limited to: Empirica, Clinical and Safety outputs, Literature, and HA requests - Assists in evaluation and development of Safety Management Plans - Assists in data analysis compilation and presentation at cross-functional meetings. - Assists in the evaluation of potential safety issues. - Contributes to activities related to the functioning of safety committees, including but not limited to, preparing reports, minutes and meeting documents; ensuring completion of action items; and, participating in the discussion of patient safety issues. - Contributes to the development and management of SOPs, work practices and guidelines, forms and templates, and other communications related to risk management and product safety. - Assists in RMP and DRMP development and updates. - Supports authoring for aggregate safety reports (eg.PSUR, DSUR, Line listings) in close collaboration with the safety product lead and operational functions

Qualifications

Education - Degree in a medical or healthcare related discipline (PharmD, RN, MD) is required Experience - A minimum of five to seven years in the pharmaceutical industry with experience in drug safety/pharmacovigilance. - Previous experience in managing drug safety personnel a plus. - Specific experience in RNA therapeutic area at a global level is an advantage. Skills and Competencies - Strong skills and experience in: - Ability to work in a matrix environment in accordance with the company leadership commitments and values. - Excellent planning, organization, written and oral communication skills - Advanced knowledge of Global (including US, EU, LATAM, APAC) Pharmacovigilance regulatory requirements - Understanding Signaling tools (eg. Empirica) - Experience in clinical patient care is a plus - Regulatory Inspection readiness experience is a plus Supervision - Individual is expected to work independently with support from management and colleagues in SRM. #TB_PH #ZR Why TalentBurst? - At TalentBurst, we deliver more than talent, we deliver outcomes. We partner with you to move quickly and connect you to opportunities aligned with your skills and long term growth. - Backed by precision, transparency, and results, we connect top talent with leading organizations through trusted partnerships. - We offer competitive compensation and comprehensive benefits, including medical, dental, vision, and retirement options. - TalentBurst is an equal opportunity employer committed to an inclusive and diverse workforce.