Description
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