Associate Director, Safety Operations Lead

Location
Menlo Park, CA, United States
Posted
Feb 19, 2021
Ref
1321317309
Hotbed
Biotech Bay
Required Education
Masters Degree/MBA
Position Type
Full time
Job Description
Serve as the senior safety operations expert in Corcept. Work closely with the Head of Safety and others to support all Corcept products (investigational and marketed). Responsible for safety vendor oversight. Support AE assessment, signal detection, benefit-risk evaluation, and appropriate risk management activities. Contribute to pharmacovigilance (PV) inspection and audits, and continuous process improvement.

Essential Duties/Tasks
  • Create and implement safety vendor oversight plans. Maintain good Safety Management Plans for each program. Track program spend. Escalate issues when necessary.
  • Review post-marketing safety reports in Argus.
  • Manage, co-author and review aggregate safety reports including Periodic Adverse Drug Experience Reports (PADERs), and Development Safety Update Reports (DSURs).
  • Support the development of recommendations on safety issues to the cross-functional teams and decision-making body.
  • Support clinical trial SAE reconciliations and work closely with Clinical Data Management.
  • Support consistent presentation of safety and risk management topics across various study and regulatory documents. Provide input to clinical study protocols, investigator's brochures, clinical study reports.
  • Support continuous process improvement, training and inspections and audits.

Preferred Education and Experience
  • RN, PharmD, MSc/PhD in a biological science.
  • Knowledge in oncology, endocrinology, metabolism, pharmacology, epidemiology, or other relevant specialties is a plus.
  • Vendor management experiences.
  • Expertise with Argus (or similar applications), MedDRA and WHO Drug coding dictionaries.
  • Minimum 5 years safety and PV experience in the drug development industry. Other relevant experience may be considered.

Preferred Skills, Qualifications, or Technical Proficiencies
  • Excellent communication skills (verbal and written).
  • Being proactive. Good problem-solving and project management skills.
  • Comfortable with ambiguity yet be self-motivated and timeline driven
  • Strong collaboration skills.