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Director, Drug Safety and Pharmacovigilance Compliance, Training & Infrastructure

Cambridge, MA 02142

Posted: 08/13/2019 Employment Type: Direct Hire Job Category: Clinical: Pharmacovigilance (PV)/Drug Safety Job Number: 2411

Reporting to the Vice President of Drug Safety & Pharmacovigilance, the (Sr.) Director of Drug Safety and Pharmacovigilance Compliance, Training & Infrastructure (DSPV-CTI) is responsible for the management and oversight of pharmacovigilance (PV) quality and compliance across the PV system, PV inspections and audits, PV activities including QC of aggregate reports and metrics, partner relationship management, PV training and education, and CRO and vendor management. The successful candidate will be responsible for ensuring compliance with regulatory requirements and corporate and departmental procedures. This position requires ability to influence without directly managing and partnership with internal and external colleagues in matrix teams and with senior management.

Responsibilities Include:
  • Oversight of pharmacovigilance (PV) quality and compliance system including establishing standards, department training requirements, monitoring department performance, implementing continuous improvement actions and good documentation practices.
  • Collaboration with QA department to maintain a state of high PV inspection readiness across all regions/countries, provide support for inspections and audits.
  • Maintain high level of knowledge of current global pharmacovigilance regulations, updates to regulations and good pharmacovigilance practices
  • Partner with PV Operations in the generation, review, approval and operational implementation of governing documents, such as SOPs and Work Instructions, as necessary.
  • PV Vendor oversight, including key performance indicator (KPI) metrics generation and review, contract compliance, quality and timeliness of deliverables and continuous improvement. PV vendors can include database providers, CROs and other vendors as needed.
  • Ensure inspection readiness of vendors conducting PV activities through above-referenced KPI metrics review, vendor audit findings, CAPA generation and review.
  • Provide functional support / input into PV vendor relationships including safety database holders, CROs and other vendors as required (e.g., business requirements, vendor selection, contract details).
  • Support partner relationships through participation in Joint Pharmacovigilance Committees; generate and maintain Safety Data Exchange Agreements, as necessary; partner with PV Operations with regard to operational implementation of SDEAs/PVAs.
  • Provide support for department activities, including but not limited to review of core documents including Investigator Brochure (IB), protocols and aggregate reports.
  • Provide program management support for department initiatives, including activities required in preparation for product launch
  • Provide pharmacovigilance training and training documentation for investigator meetings, vendors, CROs and partners, as required.
  • May include direct supervision and management of internal safety infrastructure personnel as the department expands.

Requirements / Qualifications:
Preferred Qualifications:
  • 10 years’ experience in pharmaceutical PV quality and compliance required.
  • Master’ s or Doctorate level degree in health care related profession preferred.
  • Minimum 5 years’ experience working with CROs, vendors, and relationship management preferred.
  • Successful leadership / senior level experience in global pharmacovigilance quality and compliance oversight
  • Experience with selection and working with contract service providers for case processing, aggregate reporting and quality management activities.
  • Extensive experience in performance management of PV systems.
  • Experience with regulatory inspections and company audits including MHRA/EMA PV inspections.

Basic:
  • BS degree in nursing, pharmacy, or other health care or life sciences related profession
  • 5 years’ experience in Drug safety/Pharmacovigilance quality and compliance in a pharmaceutical industry setting or the equivalent
  • Ability to work independently and productively and set priorities across multiple projects with little supervision.
  • Strong experience with safety databases, clinical databases and data evaluation tools (e.g., Oracle Argus, Medidata, eClinical)
  • Exhibits leadership skills that promotes team collaboration, fosters open dialog, maintains an inclusive collaborative environment, keeps a team focused on a common goal and maintains positive momentum through difficulties.
  • Must work effectively/collaboratively in a fast-paced team environment and with individuals at all levels within an organization.
  • Proven ability to lead a cross-functional, matrixed team.
  • Expert knowledge of FDA and EU legislation and ICH PV guidelines.
  • Prior NDA / MAA experience preferred.
  • Strong analytical and problem-solving skills with superb attention to detail.
  • Strong verbal, written technical communication and presentation skills

Aaron Goldman
Clinical Recruitment Team Lead

Aaron is a spirited guy who likes to make things happen. He has been a Clinical Recruiter for the past five years, and says his greatest reward comes when a candidate accepts an offer and he hears the excitement in their voice - You know you have helped someone change their life!
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