RaleighRecruiter Since 2001
the smart solution for Raleigh jobs

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.

Keywords: Coastal Search Associates, Raleigh , Senior Director Drug Safety, Executive , Raleigh, North Carolina

Click here to apply!

Didn't find what you're looking for? Search again!

I'm looking for
in category
within


Other Executive Jobs


Sr. Director, ACO Performance
Description: Thank you for considering a career at Evolent Health. Please take a minute to fill out the following
Company: Evolent Health
Location: Raleigh
Posted on: 03/1/2021

VP Sales Operations
Description: Our VP of Sales Operations--leads the sales operations team, processes, and tools to drive world class sales force productivity and serves as a strategic partner to the sales leadership team. The candidate's (more...)
Company: ExecuNet
Location: Raleigh
Posted on: 03/1/2021

Regional Director of Facilities
Description: Since 1985, Concord Hospitality has maintained an unparalleled standard of excellence across all capabilities as hotel developer, owner and operator, providing dedicated hotel management services to both (more...)
Company: Concord Hospitality
Location: Raleigh
Posted on: 03/1/2021


Assistant Manager - Hospitality - #589 - Evenings/Overnight
Description: Assistant
Company: Sheetz
Location: Garner
Posted on: 03/1/2021

IT Security Architect Program Director
Description: Overview Connvertex is seeking a--IT Security Architect Program Director--with our direct client. Title: IT Security Architect Program Director-- br Location: Raleigh NC br Duration: 12 Months Required (more...)
Company: Connvertex Technologies Inc
Location: Raleigh
Posted on: 03/1/2021

Nurse Director of Pediatric Telemetry
Description: Explore this new and exciting opportunity as the Director of the--Pediatric Telemetry Service Line at this highly reputable, award winning hospital in beautiful North Carolina.--Learn how you could--become (more...)
Company: Clinical Management Consultants
Location: Selma
Posted on: 03/1/2021

assistant general manager
Description: Job DescriptionPrimary Responsibilities Knowledge to review and analyze P L statement Provide GAS3 selling experience for DIY and DIFM customers Achieve personal / store sales goals and service objectives (more...)
Company: Advance Auto Parts
Location: Wake Forest
Posted on: 03/1/2021

Director of Demand Generation
Description: Company DescriptionOver the last 20 years, Intelerad has grown into a leader of the medical imaging software industry. Our distributed solutions play a vital role in the delivery of healthcare across (more...)
Company: Intelerad Medical Systems
Location: Raleigh
Posted on: 03/1/2021

Assistant Salon Manager - Publix Pointe
Description: Assistant Salon ManagerGot shears and a winning attitude Have a yearning to earn and a desire to support other stylists Then let s talk Maybe you re a stylist who wants more
Company: Great Clips
Location: Coats
Posted on: 03/1/2021

Application Environment Manager
Description: Credit Suisse is a leading global wealth manager with strong investment banking capabilities. Headquartered in Zurich, Switzerland, we have a global reach with operations in about 50 countries and employ (more...)
Company: Credit Suisse
Location: Raleigh
Posted on: 03/1/2021

Log In or Create An Account

Get the latest North Carolina jobs by following @recnetNC on Twitter!

Raleigh RSS job feeds