Job Description Position : Pharmacovigilance ScientistOffice/Work Location : Chandigarh, IndiaCompanyOverview CONTINUUM is a contract research organization offering Regulatory, Pharmacovigilance, Clinical Data Management (CDM), Statistical Programming, Evidence Evaluation and Technology Solutions. These service areas cover planning, launch and lifecycle management of Pharmaceutical, Consumer products and medical devices. We are based out of Chandigarh and are currently hiring for our Pharmacovigilance Team.Basic Function: Responsible for processing of Individual Case Safety Reports (ICSRs), preparation of aggregate reports and activities related to signal management.Principal Functional Responsibilities: Manage activities relating to the processing, follow-up, analysis, and regulatory reporting of adverse events (AEs) and serious adverse events (SAEs) in ICSRs for marketed and investigational human and veterinary products in accordance with the applicable regulatory requirements Preparation of Scheduled and Unscheduled Aggregate report [e.g. Periodic Benefit Risk Evaluation Reports (PBRERs)/ Periodic Safety Update Reports (PSURs), Addendum to Clinical Overviews (ACOs), Addendum PSURs, PSUR Line Listings, US Periodic Adverse Drug Experience Reports (PADERs), Signal Evaluation Reports (SERs)] from aggregate data for products, in accordance with client conventions and requirements Quality checks of aggregate reports Signal detection-related analyses and reports including cumulative analyses, issue event analyses Interacting with internal or external contacts to resolve issues related to the processing of ICSRs, aggregate reports and related processes Maintaining a good working knowledge of the Adverse Event (AE) safety profile of assigned drugs, labelling documents, data capture conventions, guidelines, client procedures and international drug safety regulations Maintaining an awareness of global regulatory reporting obligations to ensure compliance with internal and regulatory timelines Note: The above statements describe the general nature and level of work being performed, and are not an exhaustive list of all responsibilities required for the position.Qualifications and Experience: -Science/Medicine degree: The minimum qualification required would be a Masters degree in Life Sciences (Pharmacy, Microbiology, Biochemistry, Biotechnology, Biophysics etc.) or Bachelor degree in Veterinary Sciences or Post-Graduation in Veterinary Sciences -A degree in Dentistry would be an advantage (BDS/MDS) -Experience in pharmacovigilance/drug safety or allied fields would be an advantage -Computer proficiency, an ability to work with web-based applications, and familiarity with the Windows Operating System and the MS Office suite (Word/Excel/ Power Point) -Good knowledge of medical terminology -Fluency in written and spoken English -Ability to evaluate data and draw conclusions independently -Capability to make concise, accurate and relevant synopses of medical text and data, and the ability to write unambiguous medical text -High level of flexibility and ability to (re)prioritize work -Typing and transcription accuracy -Attention to detail -Team Player
Job Title
Pharmacovigilance Scientist