- Title: Regulatory & Medical Affairs - Physician
- Code: RCI-31993-1
- Location: Lawrenceville New Jersey (NJ) 08648
- Posted Date: 07/02/2020
- Duration: 12 Months
Talk to our Recruiter
- Name:Vishal Trivedi
- Email: email@example.com
- Phone: 908-704-8843 ✖ 435
Department Title and Description
- Medical Safety Assessment, Global Pharmacovigilance & Epidemiology, Research & Development
Purpose/Objective of the job:
- Medical safety lead for aggregate safety reports and strategic documents, eg, safety aggregate reports and risk management plans
Key Responsibilities and Major Duties:
- Leader or key contributor to safety query responses.
- Plans risk strategy, risk assessment, and risk minimization for Client products in partnership with other Client functions
- Supports and/or Chairs Medical Surveillance Teams (MST) in overseeing and conducting safety data analysis
- Primary role: Medical safety lead for aggregate safety reports and strategic documents
- Capable of reviewing data to perform Signal Detection/Safety surveillance; can evaluate and integrate data from multiple sources, including clinical, nonclinical and real-world, to understand and manage safety signals
- Serves as safety consultant for product development activities.
- Medical competency and scientific analytic skills
- Internal Matrix: Safety Scientist, Scientific Writer, Epidemiologist, Clinical Safety Program Lead, Medical Review Safety Physician, Therapeutic Area Head, Administrative Assistants
- External Matrix: Medical Team Leads, Development team leads, Medical Monitors, Global and Regional Regulatory Leads, Biostatistics Lead, Operation Lead, Pre-Clinical Safety Lead (Drug Safety Evaluation), Labeling Lead Clinical Leads, Project Management as appropriate to stage of development, business partner(s) as appropriate
- MD or Equivalent. Has completed a Board certification and/or relevant higher medical training.
Experience – Responsibility and minimum number of years
- Generally, has 3 or more years previous experience as medical safety assessment physician; recent experience in early drug development (pre-approval)
Competencies – knowledge, skills, abilities, other
- Understanding of regulatory requirements for safety assessment and action through the life cycle of a drug product.
- Understanding of drug development process, with knowledge of design and execution of randomized clinical trials
- Strong scientific analytical reasoning skills
- Clinical knowledge base as demonstrated by clinical practice experience, or comparable activity
- Strong written and oral scientific communication skills
- Behavioral competencies necessary to work and lead within a complex matrix environment
- Knowledge of pharmacovigilance and ability to apply knowledge to evaluation of safety concerns and minimization of patient risk throughout the life cycle of a drug product
- Ability to leverage the range of available tools to investigate safety concerns, including the science of observational research.