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Director / Senior Director, Pharmacovigilance

Position Summary: 

Reporting to the Head of Pharmacovigilance, the Director/Senior Director of Pharmacovigilance Operations will be accountable for ensuring effective, high quality and efficient management of operational deliverables and strategic planning for departmental needs, to ensure compliance with applicable global regulations and guidelines.  


Essential Functions:  

  • Provide strategic planning, implementation, and management of PV’s operations activities.
  • Provides expert guidance and leadership both internally and externally based on in-depth knowledge of development and post-marketing safety requirements, per ICH; US and international regulations and guidelines; and Good Pharmacovigilance Practice (GPvP). 
  • Accountable for identification, development and implementation of PV process improvements, tools, systems and procedures to enable excellence and consistency in operations. 
  • Ensure implementation of standardized processes and procedures (SOP) for PV Operations activities to ensure global compliance, including Adverse Event (AE) processing and aggregate reporting.
  • Supervise operations personnel (direct reports, consultants) including mentoring and training.
  • Establish PV CRO oversight procedures and Key Performance Indicators (KPIs).
  • Ensure that the PV Database supports the department needs and provides oversight of systems and MedDRA updates in collaboration with the relevant PV CRO.
  • Responsible for timeline management and ensuring global submission of aggregate safety reports and line listings such as DSURs and other aggregate safety reports (e.g.; PSURs/PBRERs) as required.
  • Support training of department personnel and other line functions involved in AE collection or processing such as Medical Affairs, Sales, Marketing, etc.
  • Responsible for the creation, oversight and management of global business partner safety data exchange agreements/ pharmacovigilance agreements and other contracts as applicable to ensure compliance with data exchange activity.
  • Develop and implement an inspection readiness program with the contribution of other PV and non-PV stakeholders.
  • Work with QA/Compliance to ensure compliance of PV Operations procedures and training.
  • Ensure compliance-related investigations, and development and implementation of corrective actions for deviations from case processing procedures are performed accurately and on time.
  • Participate in regulatory inspections and audits to ensure the quality, integrity and compliance with pharmacovigilance and safety reporting requirements, including authoring of responses to findings relevant to functional area.
  • Participate in departmental budget planning and management.
  • Represents PV as a leader on project teams, other departments, and committees as needed.
  • Assist in the preparation of relevant sections of clinical study reports, annual reports, expedited safety reports and other regulatory filing documents.
  • Provide expert safety/pharmacovigilance guidance to clinical trial project teams and/or external partners to develop procedures and logistics for clinical trials.
  • Effectively collaborate with key stakeholders at all levels in the organization.  including Clinical Operations, Clinical Development, Regulatory Affairs, Legal, Medical Affairs and Manufacturing to develop compliant procedures in line with industry standards and best practices.


Preferred Experience:

  • At least 7-10 years of experience in global PV for a biotechnology or pharmaceutical company in the clinical trial and post marketing environments. A minimum of 6 years of functional management experience overseeing PV staff
  • Expert knowledge of FDA safety regulations, ICH Guidelines, Good Pharmacovigilance Practice (GPvP) and other applicable regulatory guidance documents.


Preferred Education:

  • Typically requires an advanced degree in life sciences, nursing, pharmacy or medicine, (eg. PhD, PharmD, RN, MD).


Preferred Additional Skills:

  • Demonstrated ability to prioritize and solve problems with innovative solutions along with strong organizational skills
  • Possess strong and dynamic leadership skills, with excellent written, verbal and presentation skills
  • Effective team player, fosters collaboration within and across functional areas.
  • Sound strategic evaluation, analysis, and decision-making skills
  • Able to handle pressure in a dynamic, fast paced environment.
  • Effectively formulates strategies, tactics and action plans to achieve results.
  • Ability to balance competing interests of various stakeholders and strive for achieving mutually beneficial and compliant solutions
  • Current US work authorization required
  • Ability to travel domestically and internationally
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