Overview:
The Director, Pharmacovigilance Compliance (PV Compliance) will report to the VP, Global Drug Safety & Risk Management. The Director PV Compliance is a key role and will provide expertise and leadership in developing, implementing, and maintaining a robust global compliance program within the GDS&RM. The PV Compliance manager will also be responsible for ensuring appropriate and applicable training of GDS&RM staff to ensure compliance with good PV practices, development of metrics and reporting to senior management across all PV activities including but not limited to: case management and reporting, management of external PV vendors, and lead the action plan and resolution of inspection/audit findings and/or corrective actions; preventative actions (CAPAs).
The Director, PV Compliance will also participate in department and cross-functional meetings with regulatory affairs and quality teams, as well as other intra and/or inter-departmental activities and initiatives.
This position is based in our Woburn office and welcomes hybrid work! Local candidates are expected to be on-site 2 days per week.
Responsibilities:
Responsibilities
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Assess and develop a robust, global pharmacovigilance program
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Develop key metrics and reporting process for these metrics to senior management
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Work closely with all stakeholders in the GDS&RM to understand existing processes and procedures, and identify gaps and opportunities for improvement in both effectiveness and efficiency
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Partner with members from the Quality Department to align compliance process and procedures with existing or required quality processes
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Develop a professional relationship with existing pharmacovigilance vendors and establish a management and oversight program to assess both the quality and the compliance of deliverables
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Assist with end-to-end case processing activities, as needed, within the ARGUS safety database; checking patient narratives, performing quality checks, querying clinical sites
- Participate in both departmental and cross-functional meetings and initiatives to increase the awareness, education, training, and leadership for PV compliance
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Identify and support training programs for members of the GDS&RM department
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Develop SOPs and Work Instruction (WI)
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Establish and maintain PV inspection readiness in collaboration with GDS&RM subject matter expert (SME) and act as company’s representative during regulatory agency inspections and vendor audits
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Ensure that a risk-based audit plan is developed, designed and implemented, and that the activities are conducted, reports written according to SOPs and that QEs/CAPAs are written, reviewed and followed up
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Structure and conduct internal Pharmacovigilance systems audits
Other activities, as needed or as requested by manager
Qualifications:
Qualifications:
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Bachelor’s degree in the life sciences or related will be considered with applicable job experience.
- 5+ years of experience or the equivalent combination of education and experience.
Experience and skill requirement:
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Solid medical knowledge and understanding to support safety reporting
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Oncology experience preferred
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Physical Requirement: Subject to extended periods of sitting and/or standing, vision to monitor and moderate noise levels. Work is generally performed in an office environment.
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Knowledge of GCPs, GVP, ICH guidelines and FDA regulations and familiarity with EMA regulations and guidelines, and other international regulatory requirements.
- Strong knowledge, understanding, and familiarity with ARGUS, with experience in end-to-end case processing for oncology events coming from development program(s)
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Experienced and demonstrated success in the development and implementation of compliance processes in a pharmacovigilance setting
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Ability to multi-task in a high-paced, fast-moving environment with changing priorities
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Solid written and oral communication skills
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Detail and solution-oriented, able to think outside the conventional “Big Pharma’ mentality, and comfortable working in a small company/biotechnology enfironment
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Able to work both independently and in a team environment.
- Proficient in standard computer software (Word, Excel and Power Point)
Location:
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This position is based in our Woburn office and welcomes hybrid work! Local candidates are expected to be on-site 2 days per week.