Senior Director Drug Safety
Company: Coastal Search Associates
Location: Raleigh
Posted on: February 23, 2021
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Job Description:
. Previous Drug Safety experience in pharmacovigilance and
clinical risk management of clinical drug development in the
biotech/pharmaceutical industry. You will lead and direct global
safety projects providing continuous assessment, management and
timely communication of the benefit/risk profile for company
products in clinical development
from early to late stage clinical development. You will be
responsible for establishing the direction and priorities the
Global Safety Team and is accountable for all product safety
related decisions for
assigned compounds in clinical development including post-marketing
studies.
You will be the key interface between the Global Safety Team,
Therapeutic Area Head, Global Safety Senior Management, Regulatory
Affairs and other
company functional areas including Global Development.
Responsibilities include but are not limited to:
Lead responses to regulatory inquiries regarding safety, including
evaluating questions, assigning responsibility, determining data
needs, reviewing, approving and submitting the
response.
Develops and supports action plans to evaluate safety concerns,
internal review and escalation, risk management strategy,
execution, and communication
Lead development of strategy and creation of product risk
management plans including maintenance and updates.
Manages quarterly product safety reviews execution and closure of
recommendations.
Represent Global Safety in meetings with Regulatory authorities
Participate in planning, review and sign off of clinical trial
safety documents for content (includes CSS, 120 Day safety reports,
updates, protocol safety sections, CSRs, ICFs, study safety
monitoring plans, and Investigator Brochures.
Provide input to potential in-licensing opportunities, safety
interactions, and pharmacovigilance agreements with commercial
partners. Job Qualifications: MD required--Minimum of 10 years
Pharmaceutical/Biotech industry experience, including time managing
clinical trials and/or clinical development program(s)
--- Board certification/eligibility
Preferred Qualifications:
Board eligibility or Board certification is preferred but not
necessary. Previous Drug Safety experience in pharmacovigilance and
clinical risk management of clinical drug development in
the biotech/pharmaceutical industry. Experience could range from 3
to 10 years. Keep up with our always upcoming news and updates.
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Keywords: Coastal Search Associates, Raleigh , Senior Director Drug Safety, Executive , Raleigh, North Carolina
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