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Manager, Pharmacovigilance Operations

MA

Posted: 11/30/2018 Job Category: Clinical: Pharmacovigilance (PV)/Drug Safety Job Number: 2060

Our client is searching for an experienced Manager of Pharmacovigilance (PV) Operations that is a creative, resourceful, and integrative thinker. The Manager of Pharmacovigilance Operations will work on projects and processes that ensure the strategies of the department are executed within global safety legislation and requirements.

The successful candidate will have a proactive and innovative approach and a flexible, hands-on nature that works with a high sense of urgency. Effective communication skills will be key as this role provides an excellent opportunity for close collaboration with colleagues from other functions such as Clinical Operations, Medical Science, Data Science, Regulatory Affairs, Quality Systems and Medical Affairs.

Roles and Responsibilities
  • Participates in the review and execution of PV Operations safety data collection strategy across clinical trial and commercial programs
  • Provides oversight and review of vendor case processing activities
  • Responsible for participating in cross-functional activities to ensure and promote compliance with pharmacovigilance data collection standards and operational consistency across clinical trials and commercial programs for all products
  • Provides knowledge into Clinical and Post Marketing teams on the needs and timelines of safety related organized data collection to ensure these needs are met and incorporated into studies and commercial activities/programs that may generate adverse event data
  • Participates in the creation and dissemination of appropriate safety reporting language in commercial and clinical trial key documents
  • Accountable for reconciliation activities between Global Patient Safety and Post Marketing programs to ensure reporting of all adverse event data
  • Actively participates in cross functional projects that develop and support strong cross-functional relationships and communication
  • Maintains knowledge of adverse event reporting process and safety system and contributes to the development, improvement and standardization of new processes and methods
  • Contributes to projects which involve the implementation of new processes and methods within and across Global Patient Safety
  • Undertake activities necessary to maintain a state of inspection readiness
  • Provides sponsor oversight of SAE processing by outsourced vendors, including the review and monitoring of compliance through various monitoring reports and other oversight activities and ensures the implementation of effective corrective and preventative action plans
  • Actively participates in the quality review of SAEs and SUSARs following data entry by vendor. Specific focus on accuracy of narrative to reflect source documentation, MedDRA coding, and appropriateness of queries to seek follow-up from the clinical sites
  • Represents Drug Safety and Pharmacovigilance on clinical development teams, as assigned
  • Participates in internal audits and global regulatory inspections including MHRA/FDA/EMA etc. as a SME for specific PV topics and processes as needed


Experience, Education and Specialized Knowledge and Skills
  • Bachelor’ s degree in nursing, pharmacy, or other health care related profession or life sciences required
  • Master’ s degree in health care related profession preferred, but not essential
  • 5-7 years of direct “ hands on” Drug Safety and Pharmacovigilance experience
  • Vendor management experience
  • Knowledge of FDA, ICH, EU Regulations and Requirements for Pharmacovigilance
  • Experience using ARISg, Argus or other Safety Database applications required
  • Strong analytical and problem-solving skills with excellent attention to detail
  • Strong verbal, written technical communication and presentation skills
  • Proficiency in standard desktop software programs (Word, Excel, Outlook)
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