For the past 20 years ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech med device and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle With deep domain expertise in regulatory sciences clinical research solutions quality compliance pharmacovigilance medical information and R D technology ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners most high-profile drug and device programs Job Summary The Pharmacovigilance PV Scientist supports the activities in the Benefit Risk group by ensuring that day-to-day operational activities are completed The PV Safety Scientist is expected to be professional and diligent and liaise with the director and management group members within the team on any issues as well as coordinate the work with the senior PV Scientists The PV Safety Scientist is also expected to lead by example and ensures quality standards are upheld within the company Essential functionsAuthoring of Aggregate reports PSURs PBRERs PADERs Annual Reports ACO DSUR for submission to local and other Health Authorities Authoring of Risk Management Plans RMPs as a part of regular Pharmacovigilance activities Authoring of Signal Management Reports Performing literature search and validity check for the aggregate reports Reconciliation of relevant process trackers Extraction and validation of data RSI Sales previous reports RMP signals Generation of Line Listings LL from safety database Providing reliable support for high priority Ad-hoc activities Necessary Skills and abilities Analytical and problem-solving skills Sound organizational skills Able to work within a team in an open and professional manner Excellent attention to detail and focus on quality Understanding of ICH-GCP FDA EMA and other relevant Global regulations related to PV Demonstrable ability to analyze and quantify large volumes of data in a concise and scientific manner in keeping with regulatory deadlines Awareness of global culture and willingness to work in a matrix environment Knowledge in other pharmacovigilance processes ability to author update SOPs or WIs to identify and author deviations CAPAs Ensuring that deliverables to the clients comply with the relevant regulatory requirements and are sent to the client within agreed timelines Capability to make concise accurate and relevant synopses of medical text and data and the ability to write unambiguous medical text Computer proficiency IT skills expertise and an ability to work with web based applications and familiarity with the Windows Operating system and the MS Office suite Word Excel Power Point Educational requirementsBachelor master s degree in pharmacy Nursing Life Science or other health-related field or equivalent qualification work experience Experience Requirements2 years experience in Pharmacovigilance with a focus on medical writing and or literature search and or signal detection Experiences in contributing to the compilation of metrics and participating in discussions about quality internally and with Clients Experience in literature screening activities and or experiences in authoring and reviewing aggregate reports We celebrate our differences and strive to create a workplace where each person can be their authentic self We are committed to diversity equity and inclusion Employees are encouraged to unleash their innovative team-oriented and entrepreneurial spirits With a holistic approach as an Equal Opportunity Employer we provide a safe space where all employees feel empowered to succeed ProPharma Group does not accept unsolicited resumes from recruiters third parties Please no phone calls or emails to anyone regarding this posting

📌 Pharmacovigilance Safety Scientist (India)
🏢 Propharma Group
📍 India