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Sr. Associate/Manager, Drug Safety and Pharmacovigilance Operations

Cambridge, MA 02139

Posted: 08/14/2019 Employment Type: Direct Hire Job Category: Clinical: Pharmacovigilance (PV)/Drug Safety Job Number: 2422

Reporting to the Associate Director/Director of Drug Safety and Pharmacovigilance Operations, the PV Project Manager of Drug Safety and Pharmacovigilance Operations (DSPV) will play a key role in drug safety operations across the clinical development programs. The PV Project Manager DSPV contributes to the day-to-day operational activities of the department and ensures that performed tasks comply with DSPV SOPs and policies, best industry standards and applicable regulations.

Responsibilities:
  • Participates in the daily management and execution of DS and PV operations.
  • Monitors compliance with regulations, PV agreements and internal SOPs.
  • Represents Drug Safety and Pharmacovigilance on clinical development teams, as assigned.
  • Provides sponsor oversight of SAE processing by outsourced vendors, including the review and monitoring of compliance through various monitoring reports and other oversight activities
  • Identifies problems, issues and takes ownership of them, and tracks them to resolution
  • Ensures the implementation of effective corrective and preventative action plans
  • Provides timely and objective feedback to outsourced vendors on SAE quality and compliance
  • Implements metric based scoring system to objectively measure outsourced vendor performance and report to management
  • Maintains PV Intelligence for SAE reporting in all of our territories
  • Provides safety operations support for external submissions, signal detection and risk management planning activities.
  • Ensures compliant exchange of safety data between company and its partners.
  • Participates in the quality management system in Drug Safety including ensuring department standards are met, including training requirements, monitoring performance, implementing continuous improvement actions and good documentation practices.
  • Works with QA department to maintain a state of high PV inspection readiness across all regions/countries.
  • Collaborates with contract service providers for case processing, aggregate reporting and quality management activities.
  • Performance management of PV systems.
  • Participates in regulatory inspections and company audits including MHRA/EMA PV inspections; prepares responses to audit findings that concern the DSPV department.

Requirements/Qualifications:
  • Bachelor’ s degree in nursing, pharmacy, or other health care related profession or life sciences preferred.
  • Master’ s or Doctorate level degree in health care related profession preferred, but not essential
  • Minimum of 2 years of experience in drug safety/Pharmacovigilance in a pharmaceutical industry setting or the equivalent.
  • Experience working with CROs, vendors, and relationship management preferred.
  • Global pharmacovigilance operations experience with products in development.
  • Safety database, MedDRA coding and data entry experience preferred.
  • Knowledge of FDA and EU legislation and ICH Efficacy guidelines preferred.
  • Strong analytical and problem-solving skills with superb attention to detail.
  • Strong verbal, written technical communication and presentation skills.
  • Must work effectively/collaboratively in a fast-paced team environment and with individuals at all levels within an organization.
  • Proven ability to work within a cross-functional, matrixed team.

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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