Senior Director Drug Safety

Company: Coastal Search Associates
Location: Raleigh
Posted on: February 23, 2021

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. Enter your e-mail and subscribe to our newsletter.

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