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Drug Safety Associate III

Remote: 
Full Remote
Contract: 
Work from: 

Offer summary

Qualifications:

Bachelor's degree in life science or healthcare; advanced degree preferred., Minimum 10 years of experience in a pharmaceutical/biopharmaceutical company., At least 7 years of Drug Safety experience with up-to-date knowledge of US and international PV regulations., Strong analytical skills, attention to detail, and problem-solving abilities..

Key responsabilities:

  • Establish and maintain departmental procedures and oversee training for continuous improvement.
  • Support pharmacovigilance activities including signal detection, literature surveillance, and medical review oversight.
  • Collaborate with various departments and provide expertise in PV activities for clinical project teams.
  • Participate in regulatory inspections, audits, and contribute to safety analysis reports and documentation.

Katalyst HealthCares & Life Sciences logo
Katalyst HealthCares & Life Sciences Pharmaceuticals SME https://www.katalysthls.com/
51 - 200 Employees
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Job description

Responsibilities:
  • Establishes and maintains departmental procedures; oversees training and continuous improvement.
  • Support DSP in pharmacovigilance activities including: signal detection and tracking activities, literature surveillance, oversight of medical review performed by outsourced vendor
  • Collaborate with DSP safety physicians with PV activities as assigned
  • Writing safety analysis reports
  • Oversight of medical review and aggregate report activities performed by outsourced vendors
  • Support clinical project teams for investigational products; provide project teams providing expertise in PV activities
  • Collaborate with Clinical Research and Development, medical Affairs, Regulatory Affairs
  • Provide Leadership in the development, implementation, and maintenance of robust procedures for PV activities within the DSP department
  • Participate on the Safety Evaluation Group with local and global drug safety colleagues to monitor and discuss safety signal evaluation topics
  • Contribute to the writing and compilation of PADERs, Annual reports and PSURs/PBRER.
  • Author and review department SOPs as needed.
  • Participate in Regulatory Inspections, external audits and investigator meetings
  • Drug safety representative on Purdue intradepartmental committee for review and approval of clinical trial protocol language and clinical study processes
  • Acts as a Subject Matter Expert in PV regulatory inspections and internal/external audits.
  • Collaborates with internal stakeholders and Purdue subsidiaries to establish and maintain the Corporate AE Policy.
  • Collaborate with Drug Safety Operations and Drug Safety Systems as needed, to ensure appropriate metrics per SOP.

Requirements:

  • Bachelor's degree (advanced degree preferred) in life science or healthcare (e.g. nursing, pharmacy)
  • Minimum 10 years of experience in a pharmaceutical/biopharmaceutical company
  • Minimum 7 years of Drug Safety experience
  • Up-to-date knowledge of US and international PV regulations and best practices
  • Thinks globally and considers present and future impacts when making recommendations
  • Experience with PV vendor and business partner oversight and contract/agreement management
  • Strong negotiation and problem-solving skills
  • Analytical skills and attention to detail
  • Accountability – takes ownership of deliverables

Required profile

Experience

Industry :
Pharmaceuticals
Spoken language(s):
English
Check out the description to know which languages are mandatory.

Other Skills

  • Accountability
  • Collaboration
  • Analytical Skills
  • Leadership
  • Detail Oriented
  • Problem Solving

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