Medical Director, Pharmacovigilance Safety Physician, Corporate Drug Safety

Hayward, CA

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OVERVIEW

We are currently searching for a skilled professional to join a well-known client’s team as Medical Director, Pharmacovigilance Safety Physician, Corporate Drug Safety in Hayward, California. Their work will have a direct impact on not just the organization but the larger clinical industry making this an amazing career opportunity.

RESPONSIBILITIES

  • Oversees the provision of medical assessments of all clinical and post-marketing adverse event case reports by CROs or business partners
  • Monitors adverse event data for all marketed products for possible product quality issues
  • Performs signal detection activities on adverse event data for all client marketed products  and in consultation with the QPPV for products in territories outside the US
  • Participates in the selection, implementation and maintenance of signal detection systems as needed
  • Manages the medical content of the safety specification, pharmacovigilance plan and risk minimization activities in the risk management plans of marketed products
  • Leads the Executive Corporate Drug Safety Committee in maintenance of benefit risk profile of marketed products; directs the creation and maintenance of Company Core Data Sheets (CCDS) and contributes to the safety sections of investigator brochures (IB)
  • Participates in labelling committees
  • Understands the role of the QPPV and contributes to the maintenance of the pharmacovigilance system and processes
  • Manages adverse event coding using MedDRA including synonym maintenance in collaboration with Corporate Drug Safety Operations
  • Reviews aggregate reports (PADERs, PSURs, PBRERs, DSURs)
  • Prepares, implements and maintains standard operating procedures (SOPs) and policies relating to pharmacovigilance (PV) and risk management to ensure compliance with regulatory requirements
  • Develops and conducts training as necessary
  • Participates in internal and external audits
  • Responsible for assisting with remediation of any Pharmacovigliance deficiencies cited during regulatory or internal audits

EXPERIENCE

  • Minimum of 5 years pharmacovigilance drug safety experience including benefit/ risk analysis and safety evaluations required
  • Experience with CNS therapeutic area is desired but not necessary preferred
  • Product launch experience is desired preferred
  • Experience with pharmacovigilance audit process. Prior experience in interactions with regulatory authorities on drug safety aspects as well as risk management strategies and pharmaco-epidemiology preferred
  • Familiarity with common adverse event management databases (e.g. Argus) is preferred Knowledge of MedDRA and WHO Drug coding dictionaries preferred
  • Ability to write SOPs and other working practices and documents within the context of clinical and post-marketing drug safety reporting required
  • Ability to write risk management plans and periodic safety reports. Excellent clinical judgment and ability to communicate complex clinical issues in a scientifically sound and understandable way required
  • Comprehensive experience with obtaining, analyzing, disseminating, and reporting safety information in compliance with safety regulations, including periodic safety reports, is required

EDUCATION

  • M.D. with a minimum of 8 years pharmacovigilance drug safety experience including benefit/ risk analysis and safety evaluations required

To be a best-fit your strengths must include

  • Strong Communicator. You will have extensive correspondence that relies on you being conversant in regulatory guidelines and clinical terminology
  • Organized. You’re an efficient time-manager and can handle the pressure of meeting multiple strict deadlines
  • Ability to work independently and with a team: You will be collaborating and often contributing to discussions amongst internal teams; you also work effectively without a lot of support or structure
  • Problem-Solvers.  As an action-oriented self-starter, you’re eager to apply your expertise in diagnosing inefficiencies, determining root causes, and recommending solutions to complex challenges
  • Personable. You establish and nurture highly effective relationships with colleagues and key stakeholders that support and advance project goals and objectives
  • Credible. Thorough understanding of clinical methodologies and providing sound analytical support, you quickly establish credibility as a reliable resource

About Advanced Clinical

Advanced Clinical is an award-winning clinical development organization that provides global services including CRO, Functional Support, Quality & Validation, Patient Recruitment and Retention, and Strategic Talent Acquisition solutions for pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations. Our mission is to deliver a truly better clinical experience for our clients and candidates. To learn more about Advanced Clinical which has been named to Chicago Tribune’s Top Workplaces, Chicago’s Best and Brightest Companies, and Best of Staffing Talent & Client, visit http://www.advancedclinical.com

Regarding your application

Please know that every completed application is carefully reviewed by the Advanced Clinical recruitment team. We understand the time commitment that is needed to prepare an application, so we respect your effort by thoughtfully reviewing and responding to each application. In return, we ask for your patience as careful review takes time, and we may not be able to respond to every application immediately

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