Director, Drug Safety & Pharmacovigilance

DIRECTOR, DRUG SAFETY & PHARMACOVIGILANCE

Tanner and Associates is recruiting for a Director of Drug Safety and Pharmacovigilance for a leading company located in the NE. The company is engaged in the discovery, development, and commercialization of products for the treatment of various pulmonary diseases.

JOB DESCRIPTION

• Candidate will be responsible for planning, developing, and managing drug safety and pharmacovigilance processes for therapeutics involving investigational and post-marketing drug studies.
• Functions include the collection, evaluation, and communication of safety information, pharmacovigilance, and safety support for clinical trials.
• Candidate will work with vendors to ensure compliance with national and international regulations and requirements.
• Pharmacovigilance activities related to the company’s marketed product are primarily conducted by its marketing partner.
• Candidate will ensure that the company follows appropriate internal processes regarding communication of safety information to its partner.
• Candidate will serve as the primary point of contact with the company’s business partners and will provide internal safety support for the R&D and marketing teams.

RESPONSIBILITIES

• Responsible for ensuring that the worldwide Adverse Drug Reporting System adequately captures safety data.
• Ensures the clinical safety of clinical trial studies meet required company and regulatory requirements.
• Evaluates adverse event safety reports and provides ongoing communication between Clinical and Global Safety.
• Maintains the Safety Management Plan/Operating Agreement between the company and the external Safety Vendors.
• Oversees the Drug Safety processes performed by vendors to ensure accuracy, medical appropriateness, and timely delivery of safety data.
• Evaluates vendor SOPs and determines vendor compliance with SOPs, ICH/GCP, and applicable regulations.
• Assists in developing audit plans of company vendors, internal safety, and pharmacovigilance operations, and ensuring that any findings from audits are properly addressed.
• Accountable for budgeting, headcount, outsourcing strategy, and management of a quality pharmacovigilance system to ensure proper risk management of company products are in compliance with all international regulations and guidelines.

QUALIFICATIONS

• Requires M.D. with advanced training in Internal Medicine. Additional training in Pulmonary/Critical Care medicine or Cardiology is a strong plus.
• Board certification/eligibility in a medical discipline.
• 5 years of industry experience in biopharmaceutical research and development or with a CRO.
• At least 3 years of experience in Drug Safety and Pharmacovigilance.
• Strong knowledge of applicable laws, regulations, guidelines, and best practices.
• Working knowledge of case processing, signal detection, regulatory reporting process, and workflow.
• Working knowledge of Medora coding and terminology.
• Experience managing CROs and other contractors.
• Experience should include investigational and postmarketing studies with proficiency in Drug Safety processes, Adverse Event Reporting, Risk Management, and Signal Detection.
• Experience writing pharmaceutical regulatory or clinical research documents, including periodic safety reports and risk management plans.