Randstad Medical Affairs in Cambridge, Massachusetts
date posted:Monday, June 19, 2017
TITLE: Medical Director
LOC: Cambridge, MA
Provide medical review individual case safety reports (clinical and spontaneous), including coding, seriousness, expectedness and causality assessment for an assigned therapeutic area.
Ensures that appropriate medical interpretation and consistency are applied to adverse event case assessment.
Perform aggregate safety data review, safety surveillance activities to review for potential safety signals and provide input to documents such as PSURs and PADERS.
Work with clinical counterparts as needed, including review clinical study protocols, development plans and serious adverse event handling.
Be the pharmacovigilance expert for assigned drugs or biologics, maintain current knowledge of full product portfolio and safety profiles for products.
Communicate and interact effectively within and across Therapeutic Teams, and within Functional Team Management as appropriate
Provide pharmacovigilance support for internal and external customer.
Essential Duties and Responsibilities:
Provide medical review of individual case safety reports, including coding, expectedness and causality assessment. Ensures that appropriate medical interpretation and consistency are applied to adverse event case assessment.
Perform aggregate safety data review, safety surveillance activities to review for potential safety signals and provides guidance on the regulatory status for expedited reporting and/or signal detection/trends.
Support internal and external customers related to the evaluation of issues and adverse events related to licensed products safety and efficacy. Shares medical/clinical expertise with counterparts in other functional areas such as quality assurance, regulatory affairs, marketing, manufacturing, and legal globally.
Provide medical and scientific expertise on pharmacovigilance matters affecting the preparation and submission of timely and accurate information to the regulatory authorities. Review and provide assurance of medical/pharmacovigilance content and clinical relevance of regulatory safety documents including Investigators' Brochures, PSURs and ad hoc regulatory reports as assigned. This includes input to PSURs and PADERS with focus on providing overview for the medical analysis and safety sections. - Work with labeling team to accurate portrays the safety profile of assigned drugs or biologics.
Serves as a medical liaison between Global Pharmacovigilance and other Business Unit medical team members.
Maintain knowledge of global regulatory authority regulations (especially FDA and EMEA)
Contribute to the training, leadership and continuing education for all departmental staff.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. List knowledge, skills, and/or abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.
Knowledge of industry regulations and drug safety practices.
Strong knowledge of adverse event case report triage processing.
Experience with commercial databases and safety coding dictionaries (MedDRA, WHOART, COSTART, etc.).
Excellent oral and written communication skills.
Excellent teamwork and interpersonal skills are required.
Strong skills in presenting drug safety topics for regulatory authorities or at conventions, meetings, etc.
Education and/or Experience:
M.D. degree required, with medical licensure in at least one state, and board certification in a specialty appropriate to the products of the division. An advanced research degree (Ph.D. or equivalent) is highly desirable.
5 years experience post-residency, with at least 3 years experience in pharmaceutical/ Biotechnology Company.
Exposure to working relationship with FDA and other regulatory authorities is preferred.
Knowledge and understanding of national and international regulatory guidelines are a plus
Knowledge of medical aspects of drug safety in Pre- and post-marketing safety practice
Strategic Planning and Problem Solving:
- Collaborate with the company businesses to ensure that all safety issues are addressed (Level 4 - Guiding) Communication with Regulators/Customers: Provide PV expertise to RA and other Customers for meetings with Regulatory Authorities (Level 4 - Guiding) Scientific/Technical Analysis: Develop a level of competence to allow conversance across the majority of scientific/therapeutic areas and potentially influence internal and external parties (Level 4 - Guiding).