Medical Director, Drug Safety

MEDICAL DIRECTOR, DRUG SAFETYJoin a leading pharmaceutical company with an extensive research and development pipeline across several therapeutic areas
The Medical Director of Drug Safety is responsible for the accurate and timely reporting of product safety information to the organization and regulatory authorities world-wide. The Director will manage safety personnel (Pharmacovigilance Managers, Associates. Etc.) and ensure that company practices meet regulatory guidelines and are uniformly implemented. The Director will also provide a medical resources to the Quality Department, Professional Services, Sales and Marketing Departments as needed.
Responsibilities:

Overseeing 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, etc.)
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 secondary to ADE associated 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
Participation in after hours medical coverage for clinical projects, if required
Assist other Medical Directors with Project Specific Safety Monitoring
Interaction with FDA and other regulatory authorities as necessary
Develop and implement Pharmacovigilance programs and risk management plans

Requirements

US Medical degree with three years experience preferred. Will consider PharmD or foreign medical degree with 5 years experience, or BSN, MSN with ten years experience.
Pharmaceutical industry experience 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
Excellent oral and written English communication skills
Significant computer / technology skills.
Prior management experience as evidence by previous direct reports
Drug development experience
Experience as direct medical liaison with FDA
Ability to prioritize and perform multiple tasks simultaneous
Ability to work well in a matrix environment, particularly with Project Management, Regulatory Affairs, Quality Assurance, Sales, Marketing and Professional Services