My client is a Philadelphia Pharmaceutical company.
Director of Drug Safety
You will be responsible for the proper and timely collection and the timely reporting of Adverse Event information from all sources as required by regulation (clinical trials, literature, direct report,
Preparation of all Safety reports (IND Safety Reports, IND / NDA updates, PSUR’s, Annual reports, etc.)
Development and maintenance of all Pharmacovigilance related SOPs
Development, Implementation and maintenance of the company safety database (s)
Prepares and reviews Adverse Event Trending reports
Prepares and reviews analysis / reports pertaining to Signal detection/surveillance activities at a medical qualitative level
Provides medical input/expertise for Data Safety Review Board reviews/label evaluations
Provides medical review/commentary and Risk Assessments related to ADE reports or associated with quality investigations on an individual case-level or aggregate review level.
Liaises with company legal consultant regarding medical review/commentary for cases of special interest and matters of regulatory interpretation.
Responsibilities include but are not limited to:
Provide medical and scientific support to Quality Assurance and Regulatory Affairs with respect to customer complaints, Adverse Event Trending and regulatory agency inquiries.
Provide medical and scientific support to Professional Services, and Marketing and Sales departments.
Medical review of documents associated with product sales and marketing
Review of protocols, case report forms, guidelines, clinical study reports and manuscripts as requested.
Protocol and/or therapeutic area training for the project team as requested
Participation in and/or presentation at Investigator Meetings as requested
Interaction with CROs, consultants, investigators, outside physicians and other medical professionals
Medical Safety support for Project Management, Data Management, Biometrics and Clinical Writing
Strategic Planning / Business Development – Assessment of Pharmaceutical Product Development and providing medical/scientific opinion of new ventures • Lead the writing of protocols, Informed Consent Forms, clinical study reports and regulatory-related documents.
US Medical degree with 3-5 years of experience preferred.
Pharmaceutical industry experience (Pharmaceutical or CRO) in Pharmacovigilance and Safety Surveillance, knowledge of drug development safety requirements and history of
experience working with safety monitors essential
Working knowledge of FDA reporting regulations as they pertain to human and veterinary drug products and medical devices for both marketed products and products under
Excellent oral and written English communication skills
Significant computer / technology skills. PV Works safety database experience a plus
Prior management experience as evidence by previous direct reports
Drug development experience.
Experience as direct medical liaison with FDA.