Drug Safety/Pharmacovigilance Specialist

RESPONSIBILITIES

* Ensure compliance with national and international regulations associated with drug safety (FDA, EMEA and other applicable regulatory bodies)
* Adhere to the appropriate SOPs
* Guarantee accuracy and timeliness of expedited reports from clinical and post marketing safety surveillance
* Author or assist in authoring applicable sections of safety reports and periodic reports
* Review published articles on relevant products for safety-related information
* Provide safety expertise related to product label
* Provide safety expertise to internal and external customers
* Assist in identifying departmental needs and advocating for appropriate resources
* Collaborate with medical, regulatory, commercial, legal and compliance teams in review of safety information included in product materials
* Engage corporate partners and establish appropriate exchange and review of safety information
* Experience with Argus required
* Responsible for case processing including but not limited to
* Prioritization of cases
* Determination of seriousness
* MedDRA Coding
* Narrative development

Required Skills

* Degree in healthcare discipline such as a PharmD, RN, Nurse Practitioner preferred
* two to four years of safety experience in a pharmaceutical company with at least 1-2 years of experience with marketed drugs
* Understanding of local and applicable foreign safety regulations
* Strong clinical background required, oncology experience preferred
* Scientific writing skills
* Detailed knowledge in the use of drug safety databases (Argus)
* Individual case-processing experience
* Practical experience working with MedDRA required
* Ability to collaborate with partners and teams with members from multiple disciplines
* Time and project management skills

Availability:

Must be available to work in the evenings and weekends, as required.

Position Location and/or Territory and Travel

* Position is located in Irvine, CA.
* Position may require occasional local travel
To find out more about Real please visit www.realstaffing.com