Pharmacovigilance Associate
hace 5 horas
The opportunity
Core member of the safety team and is responsible for performing pharmacovigilance activities within the North America PV unit, in partnership with the Drug Safety Specialists/Pharmacovigilance Safety Specialists and Pharmacovigilance Managers/Director to receive and review adverse event information for pre and post-marketed products.
Your experience and qualifications
Bachelor of Science (Physics, Chemistry, Biology, Biochemistry, microbiology, physiology, anatomy, pharmacology).
1-3 years Global experience of pharmaceutical industry or CRO experience and at least 1 year of Pharmacovigilance experience.
Demonstrates proficiency with Microsoft Office Word, Excel, PowerPoint and Adobe Acrobat. Knowledge of PhV IT systems such as Arisg, Argus, Cognos is an added advantage.
Demonstrates teamwork, critical thinking and good communication skills.
How you’ll spend your day
Intake of adverse event information, including extraction, upload and intake of XMLs
Performs case registration of adverse event reports by entering searchable information
Sending adverse event information to in license partners within the required timeline as per pharmacovigilance agreement
Collecting additional information from reporters and performing follow-up with health care professionals and consumers
Review and assessment of reportability of the adverse event to FDA/Health Canada as applicable
Receiving, reviewing and performing all necessary actions pertaining to negative acknowledgements for FDA and Health Canada as applicable
Participate in Pharmacovigilance audits and inspections as needed
Drafting and finalizing CAPAs as needed for late submissions and non-compliance with internal processes.
Complete all training and SOP/WI reviews in a timely manner
Assist in updating and revising SOPs/WIs whenever processes and procedures are changed to comply with new regulations or to improve procedures of make them more efficient
Train all the new hires in PhV on systems and processes relating to pharmacovigilance activities and present information/ training in Face-to-Face settings
Perform daily, weekly, and/or monthly reconciliations of adverse event reports with identified partners and programs as required by Pharmacovigilance Agreements, as well as source documents received from other internal departments where required
Other essential duties include drafting pharmacovigilance agendas and meeting minutes, accurately archiving pharmacovigilance documents
-
Graduate Pharmacovigilance Associate
hace 6 meses
City, México ICON plc A tiempo completoICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development. **What you will be doing**: - Perform processing for all types of safety events, medical...
-
Patient Safety Senior Associate
hace 3 meses
Mexico City Novo Nordisk AS A tiempo completoAt Novo Nordisk we don’t wait for change, we drive the change. We’re committed to promote and be an equal opportunity workplace and act as an affirmative action employer, as part of our continuous efforts to create and lead teams that have diversity and inclusion at their core. We are looking for a Senior Patient Safety Associate to join our...
-
Drug Safety Associate
hace 1 mes
Mexico City Novo Nordisk A tiempo completoAre you passionate about ensuring drug safety? Do you have a keen eye for detail and a drive to maintain high-quality standards? Join us as a Drug Safety Associate at Novo Nordisk in Mexico City. Read more and apply today for a life-changing career. Join Novo Nordisk for a life-changing career establishing and developing a world-class Global Business...
-
Patient Safety Senior Associate
hace 2 semanas
Mexico City Novo Nordisk A tiempo completoAt Novo Nordisk we don’t wait for change, we drive the change. We’re committed to promote and be an equal opportunity workplace and act as an affirmative action employer, as part of our continuous efforts to create and lead teams that have diversity and inclusion at their core. We are looking for a Senior Patient Safety Associate to join our Clinical,...
-
Patient Safety Senior Associate
hace 1 día
Mexico City Novo Nordisk A tiempo completoAt Novo Nordisk we don’t wait for change, we drive the change. We’re committed to promote and be an equal opportunity workplace and act as an affirmative action employer, as part of our continuous efforts to create and lead teams that have diversity and inclusion at their core. We are looking for a Senior Patient Safety Associate to join our Clinical,...
-
Patient Safety Senior Associate
hace 3 meses
Mexico City Novo Nordisk A tiempo completoThe position As a Patient Safety Senior Associate at Novo Nordisk, you will be responsible for receipt, documentation, triage and quality assessment of inbound safety information, including adverse events and technical complaints. Also responsible for ensuring compliance with all internal and external drug and device safety reporting requirements...
-
Patient Safety Senior Associate
hace 2 meses
Mexico City Novo Nordisk A tiempo completoAt Novo Nordisk we don’t wait for change, we drive the change. We’re committed to promote and be an equal opportunity workplace and act as an affirmative action employer, as part of our continuous efforts to create and lead teams that have diversity and inclusion at their core. We are looking for a Senior Patient Safety Associate to join our Clinical,...
