GENERAL SUMMARY: 

The Director of Pharmacovigilance is responsible for implementing and coordinating pharmacovigilance activities for 4DMT products.  This position will be a knowledge leader for 4DMT products and actively participate in safety related aspects of the product life cycle from development to post-marketing to ensure rigorous analysis, critical decision making, and communication of safety information to internal 4DMT groups and regulatory authorities.  It is expected that this person will develop a proactive, forward-looking program of communicating safety information and directions for safety product use to stakeholders both internal and external.  Knowledge of safety operations and systems is important to this position.

The person will be a key interface and participant with internal 4DMT groups such as Clinical Science, Clinical Operations, Regulatory, and Compliance/Quality. Documentation of the origin, ongoing history, and closure of safety issues will be critical.

The person will ensure corporate compliance with domestic and international adverse event and safety issue reporting requirements, interpreting the medical significance of incoming safety information, and performing regular risk management assessments of assigned products. 

RESPONSIBILITIES:  

• Act as safety leader with responsibility for signal detection and assessment activities for 4DMT products. Example:
  • Signal summary reports;
  • Tracking and using safety database tools for aggregating safety data; 
  • Leading cross functional teams to assess safety signals; 
  • Creation of action plans to mitigate/manage product risks; 
  • Responding to safety associated Health Authority requests; 
  • Development and maintenance of product Risk Management Plans (RMP); 
  • Monitor the safety profile of delegated products and recommend appropriate action including labeling amendments and risk management programs when warranted assess product specific adverse event information to determine required action based on internal policies; 
  • Providing medical assessment as relevant.
• Participation in maintaining and upgrading pharmacovigilance processes. These may include MedDRA maintenance, PV systems policies, and implementation of new regional and cross-regional PV regulations. 
• Ensures corporate compliance with domestic and international adverse event and safety issue reporting requirements for delegated products.
• Prepare safety-related sections and associated documentation for clinical and regulatory documents (i.e. clinical study protocols, clinical study final reports, IND annual reports, integrated summaries of safety, annual safety reports, Investigator Brochures, Development Safety Update Reports (DSUR), and Annual safety update reports (ASUR), and other aggregate reports).
• Review ICFs, clinical study non-serious adverse event line listings and other study related documents containing safety information.
• May assist with approving, reviewing, and contributing to publications (abstracts, posters, papers) for scientific meetings/journals.
• Assists with contributing to safety components of strategic documents and to development of Target Product Profile (TPP).
• Act as the safety liaison/resource on study project teams for safety related issues relating to clinical development.
• Supervise PV activities and personnel related to licensing partners and CROs.
• Provides support as required for licensing activities, regulatory authority inspections audits and for project product recall activities.
• Collaborates with other departments (e.g., training) to provide expertise and guidance to personnel for interdepartmental and cross-functional team activities, including process improvement standards and metrics.
• Interacts with service providers as required to address safety queries, share best practices, and discuss new safety regulations.

Provides regional support for activities associated with safety compliance, operations, and medical review as needed. 

QUALIFICATIONS: 

• MD, PharmD., RN, BSN, Nurse Practitioner, Pharmacist or related degree with at least 5+ years pharmaceutical industry, pharmaceutical industry safety surveillance, or applicable clinical/medical experience required.
• Demonstrated knowledge of domestic and international ADE reporting regulations per guidelines and follow timelines as necessary for regulatory reporting purposes.
• Demonstrated knowledge and proficiency with drug safety databases (i.e. ARISg or ARGUS)
• Proficiency with standard office skills and standard desktop computing programs
• Excellent oral and written communication skills with excellent interpersonal skills and willingness to work in a team environment, cross functionally, and work with multiregional organizations.
• Highly organized and demonstrates understanding of workflow prioritization.
• Ability to multitask and triage as needed with the ability to work independently, under pressure, demonstrating initiative and flexibility.
• Excellent understanding of clinical trial methodology, GCP and medical terminology
• Attention to detail and quality focused with strong technical and problem-solving skills

• Strong organizational and project management skills

• Strong communication skills and the ability to operate effectively in an international environment

• Excellent understanding of physiology, pharmacology, clinical study objectives, and the drug development process
• Strong computer skills including, but not limited to, creation of spreadsheets, templates, presentations and working with safety database applications.

Compensation Range: $210,000/year - $270,000/year

Please note, the base salary compensation range and actual salary offered to the final candidate depends on various factors: candidate’s geographical location, relevant work experience, skills, and years of experience.