Job Description
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 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 industry experience in biopharmaceutical research and development or with a CRO.
At least 3 years 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 MedDRA coding and terminology.
Experience managing CROs and other contractors.
Experience should include investigational and post-marketing 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.
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Job Tags
For contractors, Worldwide,