PV Scientist 2
Iqvia•3h ago
Bangalore, IndiaOnsiteFull-timeMid Level5+ yrs exp
Top focus
Data ScientistApplied ScientistResearch Scientist
- Principal responsibilities include:
- Coordinates all aspects of signal detection and safety surveillance and review activities, in collaboration with or as GSL, for assigned product(s). Accountabilities (primary duties and responsibilities of the job):
- 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 authoring of safety evaluations, defining scope and methodology and providing background information for aggregate safety reports, conducting preliminary safety analyses
- preparing ad hoc reports including Health Hazard Evaluations, Signal Evaluation Reports
- Health Authority responses in collaboration with GSL for assigned product(s)
- In collaboration with GSL, work 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 other relevant functional areas both within and outside of global PV to best ensure the most efficient and timely attainment of compliant and patient focussed safety data.
- In collaboration with GSL, represent pharmacovigilance department in cross-functional teams with the advanced communication skills this requires.
- Assist with the preparation and presentation of identified and potential patient safety risks to SMT on safety issues.
- 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 in Company Core Data Sheet (including Reference Safety Information) and Investigator Brochure, as well as other labeling documents in collaboration with GSL.
- Demonstrate outstanding knowledge of local and global health authority requirements.
- Support GPSE in the maintenance of a highly effective global safety organization in full compliance to worldwide regulations. EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
- Bachelor of Science or Health Care Professional degree (e.g., RN, BSN, NP, PA, RPh) or equivalent qualification; advanced degree in scientific or medical field preferred.
- Minimum 5 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. Additional Us Specific Information (For US Recruitment Only):
- Bachelor of Science or Health Care Professional degree (e.g., RN, BSN, NP, PA, RPh) or equivalent qualification; advanced degree in scientific or medical field preferred.
- 5 years of relevant biotech/pharmaceutical experience. Additional Europe Specific Information (For European Recruitment Only):
- Bachelor of Science or Health Care Professional degree (e.g., RN, BSN, NP, PA, RPh) or equivalent qualification; advanced degree in scientific or medical field preferred.
- 5 years of relevant biotech/pharmaceutical experience. IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations
- material omissions during the recruitment process will result in immediate disqualification of your application
- termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.
Required skills
pharmacovigilanceclinical trial methodologysafety data analysisbenefit-risk assessmentadverse event codingproject managementMicrosoft ExcelMicrosoft PowerPointMicrosoft Word