Associate Medical Safety Director
7 days left
- Experience Level
Provides pharmacovigilance functional area expertise and support to project teams for assigned developmental and/or marketed products. As appropriate and exceptionally, may be the lead safety support for a compound as the Global Safety Lead (GSL). Represent pharmacovigilance, both regionally and globally.
Coordinates all aspects of signal detection and safety surveillance and review activities, in collaboration with or as GSL, for assigned product(s).
TO BE CONSIDERED FOR THIS OPPORTUNITY YOU MUST BE MEDICAL DOCTOR WITH EXTENSIVE CLINICAL EXPERIENCE TREATING PATIENTS. YOU MUST ALSO HAVE EXCELLENT EXPERIENCE OF CLINICAL TRIALS AND AT LEAST 3 YEARS OF EXPERIENCE IN PHARMA SAFETY, PHARMACOVIGILANCE OR OTHER RELATED PHARMACEUTICAL DEVELOPMENT AREA.
• The attainment of advanced compound expertise might, for exceptional individuals, allow for Global Safety Lead (GSL) responsibilities where the individual has demonstrated both the requisite depth of knowledge and associated advanced communication skills.
• Facilitate ongoing safety surveillance for assigned products, assisting with or leading data collection and assessment for the GPSE Safety Team (GST) and Safety Management Team (SMT).
• Coordinate and perform signal identification, evaluation and management activities for assigned products.
• Assist with or lead authoring of safety evaluations, defining scope and methodology and providing background information for aggregate safety reports, conducting preliminary safety analyses, and preparing ad hoc reports including Health Hazard Evaluations, Signal Evaluation Reports, and Health Authority responses.
• Partner with cross-functional colleagues of the SMT and contribute to safety-related deliverables associated with new drug applications, benefit-risk assessments and activities related to risk minimization including RMPs.
• Liaise with colleagues in relevant functional areas within and outside of GPSE to gather and provide input for appropriate sections of critical documents (e.g., protocols and amendments, ICFs, IBs, core data sheets, IMPDs, CSRs, INDs, NDAs, BLAs, and CTAs).
• Liaise with other relevant functional areas both within and outside of global PV to best ensure the most efficient and timely attainment of compliant and patient focused safety data.
• Represent pharmacovigilance department in cross-functional teams or committees and external environments at a global and regional level as required, with the advanced communication skills this requires.
• Assist with or lead the preparation and presentation of identified and potential patient safety risks and SMT recommendations on safety issues to cross-functional decision-making bodies.
• Build and maintain in-depth knowledge and understanding of designated products/studies, and close knowledge of protocols to effectively respond to safety issues.
• Ensure up-to-date representation of safety information.
• Demonstrate outstanding knowledge of local and global health authority requirements.
• Train and mentor newly hired peers and incumbent PV Scientists.
• Maintain professional knowledge and accreditation by active participation in continuing medical education activities, and foster a community of continual learning.
Education, competencies and skills:
• Medical Doctor with extensive clinical practice experience treating patients or equivalent qualification; advanced degree in scientific or medical field preferred.
• Minimum 3 years of relevant biotech/pharmaceutical experience.
• Excellent working understanding of safety database configuration and adverse event coding to direct advanced searches.
• In-depth knowledge of clinical trial methodology, pharmacovigilance regulations, safety data analysis and benefit-risk assessment, and understanding of drug development.
• Good critical/analytical thinking and project management skills.
• Ability to review, analyse, interpret and present complex data to a high standard, with keen attention to detail.
• Proficient in all communication skills, with the agility to respond to different audiences in a clear and concise manner.
• Good level of computer literacy with commonly used software (e.g., Microsoft Excel, PowerPoint, Word).
• Team player that performs effectively in a fast-paced, cross-functional environment.
• Excellent organisation skills and ability to prioritise independently (with minimal supervision).
• Ability to coordinate, moderate, and clearly document conclusions of cross-functional scientific meetings.
At IQVIA, we believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. The advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our 67,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com.