Medical Director, Drug Safety & Pharmacovigilance

Purdue Pharma   •  

Stamford, CT

8 - 10 years

Posted 166 days ago

This job is no longer available.

The Medical Director is responsible for all activities necessary for anticipating, detecting, and analyzing product specific safety issues; ensuring proper monitoring and assessment of safety signals and determining their impact on labeling or continuation of drug development; and, for working within the assigned Asset Team(s) to set the strategy for safety activities relevant to development projects. The position supports the Executive Medical Director, DS&P, in ensuring continued surveillance of company products, in management of safety related issues for pipeline and marketed products, in ongoing assessment of potential drug-related toxicities, and in balancing the benefit risk profile of company Purdue Pharma LP products. Medical Director provides medical and pharmacovigilance expertise to lead decision making based on ongoing benefit-risk assessment, pharmacoepidemiological or clinical trial data interpretation, and risk evaluation and mitigation.

Primary Responsibilities:

*      Perform oversight of Medical Review function in compliance with all regulations and guidelines; consult with Head of Operations to assign medical review responsibilities to qualified staff and CRO personnel

*      Prepare periodic reports in compliance with all regulations and guidelines within specified deadlines for each product; accountable for processes to generate PBRER (Periodic Safety UpdateReport): assign responsibility to support data generation as appropriate, define and perform required analyses, write PBRER sections and conduct benefit risk assessment, perform final review and revision. Review and provide feedback on PSURs generated outside the US

*      Perform a review of the scientific literature: identify case reports that meet criteria for entry into the safety database; identify relevant safety articles / references involving the active ingredients of marketed products and products in development; and create literature summary sections to be included in PSURs and other requiredreports

*      Conduct signal detection surveillance activities including:

o Review and interpret safety data to detect possible AE signals

o Review of case series

o Conduct disproportionality analysis for PPLP products and adverse event combinations within FDA AERS database

o Prepare Safety Analyses and Risk Benefit Assessments

o Propose labeling initiatives

*      Review CCSI (Company Core Safety Information) sections the CCDSs (Company Core Data Sheets) under US responsibility according to schedule

*      Notify Regulatory Department of all changes to CCSI and supply related documentation

*      Develop and maintain SOPs (Standard Operating Procedures) and WPDs (Working Practice Documents) related to Medical Drug Safety (DSM)

*      Liaise with IAC-DSC (International Associated Company * Drug Safety Center) Directors for day-to-day coordination and issue resolution

*      Provide guidance and help drive the understanding and alignment among case handling, aggregate reporting, and signal detection activities

*      Reference statements and adverse events included in CCSI and lead related projects as assigned

*      Ensure compliance with relevant policies and procedures

*      Review group performance metrics

o Identify issues, analyze root causes, define improvement plans

*      Establish goals in line with department strategies and monitor progress against them

o Lead definition and implementation of change initiatives aligned with vision and strategies

*      Drive resolution of complex, cross-functional issues

*      Drive the Lifecycle Safety Risk Management processes

*      Actively participate in the core team and clinical sub-team meetings for assigned marketed and / or investigational products

*      Participate in the development of pharmacovigilance plans / development Risk Management Plans (DRMP) for PPLP marketed / investigational products

*      Prepare responses to regulatory agency ad hoc queries and comments

*      Provide expert input on business development opportunities

Education and Experience:

   MD required; analytical training or subspecialty preferred

   Minimum 8years of experience within pharmaceutical industry and/or clinical environment required

   Minimum 5years Drug Safety experiencepreferred (minimum 3years required)

   Minimum 3years management experiencepreferred

   Experience in data analysis and aggregate reporting required

   Experience in design and analysis of observational data preferred

Necessary Knowledge, Skills and Abilities:

-      Advanced understanding of regulations and FDA, ICH, and GVP guidance

-      Advanced knowledge of the pharmacology of Purdue products and the pathophysiology of the diseases indicated for treatment

-      Knowledge of general medicine / clinical care and basic principles of epidemiology

-      Computer skills and understanding of Safety Databases

-      Working knowledge of MedDRA and WHO drug dictionary

-      Proficiency with basic MS Office applications

-      Advanced knowledge of scientific terms, medical terminology

-      Written and verbal communication skills; interpersonal skills

-      Organization skills

-      Advanced ability to develop aggregate data and interpret, analyze, and summarize information

-      Time management and ability to prioritize workload

-      Quality orientation: attention to detail, accuracy

-      Personnel management: ability to train and coach others

-      Understanding of drug safety and pharmacovigilance processes

-      Understanding of training concepts

-      Ability to influence others

-      Advanced project management skills

-      Understanding of documentation requirements in a regulated environment

-      Advanced knowledge of controlled document management systems; basic understanding of regulatory dossier management system

-      Basic knowledge of science methodology

-      Ability to work without appreciable direction toward long-range goals and objectives

Other Personal Characteristics

   Highly effective written and oral communication skills

   Proven experience in functioning independently

   Functioning in a matrix environment that interacts with functional groups within the company as well as internationally

   Articulate with strong presentation skills

   High level of energy and enthusiasm with the potential to grow in an evolving and growing organization