Pharmacovigilance and Risk Managament Consultant

Job Responsibilities:

* Work closely with colleagues in the proper gathering, evaluation, medical assessment and follow-up of individual case safety reports
* Perform clinical assessment of SAE cases reported from clinical trials; perform Sponsor causality assessment; determine regulatory reportability
* Perform review of adverse event, medical history and concomitant medication coding into WHO-Drug and MedDRA codes
* Prepare/review aggregate safety reports for submission to domestic and international regulatory authorities. Accurately identify safety issues that require further evaluation
* Identify and analyze possible trends and concerns with company products including the identification and evaluation of safety signals through the assessment of single case safety reports, aggregate trend analyses and review of relevant literature for safety information pertinent to product safety
* Contribute to and support safety sections of clinical investigator brochures, risk profiles, protocols, and regulatory reports (e.g. Annual IND report; 6-monthly line-listings; EU Annual Safety Report, DSUR)

* Contribute to and support development of evolving risk management plans
* Develop pharmacovigilance long-term plan and infrastructure (systems, processes, SOP's, etc.) to enable full compliance for both internal and partnered responsibilities

* Ensure compliance with all applicable laws, regulations and regulatory guidelines governing commercial and scientific interactions with healthcare professionals, payers, advocacy and other business partners.

* Serve as a role model for compliant behavior that is consistent with the mission, vision and values of the organization

Requirements:

* MD, PhD, or PharmD
* Minimum of 5 years' experience in a pharmaceutical, biotech, or contract research organization in Pharmacovigilance & Drug Safety or Pharmacoepidemiology
* Minimum of 2 years clinical experience in academic or private practice including hospital based setting
* Advanced knowledge in pre and post-marketing, US and international, safety regulations
* Ability to formulate and lead and investigative plan as well as develop sound risk assessment
* Advanced ability to analyze and interpret clinical data
* Experience in developing, executing RiskMaps/ Risk Management Plans.
* Understanding of, and experience with, regulatory framework applicable to interactions with HCPs, payers, advocacy and other business partners
* Strong analytical skills
* Ability to influence others (cross-functionally and within the function) to create a positive working environment
* Strong commitment to business ethics
* Passion for fighting cancer
To find out more about Real please visit www.realstaffing.com