Director - Safety and PV

Job Description:
Now is a great time to get in on the ground floor of a well-funded clinical stage pharma.
This Director (Safety and Pharmacovigilance) role is a newly created role due to continued expansion and will be both a very hands-on role (directly managing outsourced safety and PV) as well as providing strategic oversight within global safety - best practices/requlatory requirements.
This role will report directly into a Chief Medical Officer.
Responsibilities o Provides oversight and review of vendor activities.
Oversight activities include monitoring compliance, effective communication and implementation of corrective and preventive actions, as needed.
o Actively participates in the quality review of SAEs.
o Maintain PV quality and develop/update PV SOPs/training programs as necessary o Responsible for managing cross-functional activities to ensure and promote compliance with pharmacovigilance standards and operational consistency across clinical trials.
o Accountable for reconciliation activities to ensure reporting of all adverse event data.
o Maintains knowledge of adverse event reporting process and safety system and contributes to the development, improvement and standardization of new processes and methods.
Requirements -Must be based in the local Raleigh/Durham NC area o Bachelor's degree in nursing, pharmacy, or other life sciences required.
Master's or higher degree, preferred.
- Must have some recent experience working within a small clinical-stage pharma.
o 5-7 years of Drug Safety and Pharmacovigilance experience within the pharmaceutical industry (company developing their own drugs).
o Vendor management experience.
o Knowledge of FDA, ICH, EU Regulations and Requirements for Pharmacovigilance required.
o ARISg, Argus or other Safety Database experience.
o Ability to travel up to 10-15%.
I look forward to hearing from you if you meet these requirements.
Joanne Gehas, Ph.
Executive Recruiter FPC of Raleigh #FPC2019JAN

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