Manager, Global Pharmacovigilance

Confidential Company  •  Los Angeles, CA

Less than 5 years experience  •  Biotech/Pharma

Salary depends on experience
Posted on 07/22/17 by Chelsea Goff
Los Angeles, CA
Less than 5 years experience
Biotech/Pharma
Salary depends on experience
Posted on 07/22/17 by Chelsea Goff

Permanent opportunity to join a growing biotech company in Los Angeles.  Tons of growth potential and outstanding benefits, including company-paid healthcare insurance!

Primary Objective of Position

To provide proactive safety surveillance across the lifecycle of Company products, Support development and execution of Risk Management Plans, Risk Assessment, and Risk Communications pre-and- post-marketing.

Major Duties/Responsibilities

  • Perform periodic aggregate safety data review according to a signal detection strategy and escalate possible safety issues to VP of Global Pharmacovigilance and Clinical/Medical Monitor as needed for assigned product(s)
  • Collaborates with PV leader in the preparation DSURs, PSURs, PADERs, PBRERs as appropriate
  • Monitor medical and scientific literature for published articles relevant to the safety profile for assigned product(s)
  • Define search criteria (e.g., PT, SMQs), run validated database searches, and analyze data for safety signal detection in consultation with VP, Pharmacovigilance and/or Clinical/Medical Monitor
  • Plan and perform analysis in support of response to regulatory agencies, EC/IRBs and Investigators or ad hoc inquiries regarding safety issues
  • Support development and execution of risk management plans, risk assessment, and risk communications
  • Conduct safety data analysis in support of developing and updating safety sections of regulatory documents, Informed Consent, Company Core Data Sheets, product labels, etc.
  • Provide support of developing and updating Investigator Brochures and study protocols
  • Provide safety data analysis in support of Safety Review Committee (SRC)
  • Manage the relevant day-to-day aspects of safety agreement with licensing and/or collaboration partners (CRO’s)
  • Lead efforts to improve processes and increase work efficiency applicable to Pharmacovigilance
  • Remain in compliance with active Company standard processes and procedures

If required:

  • Execute triage for appropriate causality assessment on Individual Case Safety Report (ICSRs) for regulatory reporting
  • Write narratives, review of SAE for clinical content, accuracy and completeness
  • Create follow-up queries, and case follow-up measures for case processing
  • Manage and ensure compliant safety reporting in accordance with local and international reporting regulations, and/or standard operating procedures

Skills & Abilities

  • Must have the ability to work independent in a fast-paced results-driven environment
  • Ability to make basic decisions (e.g., categorizing serious and non-serious adverse events, routine coding) with an understanding of the result and impact
  • Proven ability to seek and utilize information and solve complex problems
  • Excellent interpersonal skills in developing effective relationships with safety data customers and colleagues, with the ability to communicate with diverse individuals and groups
  • Proficiency in the processing and assessment of safety data (pre-and-post-marketing)
  • Ability to critically analyze individual and aggregate safety data with scientific rigor
  • Proven ability to critically evaluate and summarize clinical and scientific data
  • Ability to create narrative/narrative summaries,  safety analysis documents, and/or safety sections of regulatory documents
  • Demonstrate computer literacy, with proficiency in the used and management of safety databases, strong computer skills such as Word, Power Point, and Excel

Physical Demands

This is an in-house position. The physical demands of the office are normally associated with extended amounts of time in front of a computer. While performing the duties of this job, the employee is frequently required to stand, walk, and sit.

Up to 10%travel (if any)

Education & Professional Experience

Education

  • BS/BAdegree in a health related (e.g., RN/BSN, RPh) or biological science field (e.g., B.S. in Biology), or advanced degree (e.g., PharmD, PhD, PA) and, minimum 3 years of biotech/pharmaceuticalexperience in Drug Safety/Pharmacovigilance

Experience

  • Minimum 3 years in Pharmacovigilance & Risk Management
  • Strong working knowledge of US/EU/AP/LA regulations, ICH, and GVP guidelines
  • Previous experience with adverse event reporting systems, FDA and EU drug safety/Pharmacovigilance requirements
  • Experience in phase I-IV drug safety surveillance and preparation of investigational and post- marketing regulatory reports
  • Experience working in electronic document management systems

Special Training

Experience with ARISg, MedDRA, WHO, ARGUS safety databases will be a plus

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