Jazz Pharmaceuticals

Senior Manager, Pharmacovigilance Process & Agreements

Job Locations US-PA-Philadelphia | UK-Oxford
Posted Date 1 month ago(1/25/2018 10:06 AM)
ID
2018-3395
# of Openings
1
Min. Exp. (Yrs)
5
Category
Research & Development

Overview

Jazz Pharmaceuticals is an international biopharmaceutical company focused on improving patients’ lives by identifying, developing and commercializing meaningful products that address unmet medical needs. We are continuing to expand our commercial product portfolio and our research and development pipeline in therapeutic areas that can leverage our unique expertise.


Our therapeutic areas of focus include sleep and hematology/oncology – areas in which we have a deep understanding of the patient journey and a suite of products and product candidates to address critical needs.


We are looking for the best and brightest talent to join our team.  If you’re looking to be a part of a company with an unwavering commitment to improving patients’ lives and being a great place to work, we hope you’ll explore our career openings and get to know Jazz Pharmaceuticals. 

Position Profile

The Senior Manager, Process & Agreements is responsible for supporting the activities performed within this group.  This position assists the leaders within Process & Agreements in the effective oversight of safety data exchange agreements with business partners and continuous improvement activities. This position will interact with internal and external customers, along with functional team members.

Essential Functions

  • Responsible for the maintenance of the global SDEA list, coordinating the initial draft, review and update activities for these agreements
  • Point of contact for assigned SDEAs
  • Entry of applicable information for SDEAs into INOVA
  • Supports the provision of information for the relevant modules and annexes of the PSMF assigned to Partner Agreements
  • Identifies and supports implementation of continuous improvement opportunities relevant to the team
  • Subject matter expert for inspections and internal audits
  • Participates and provides back-room support for internal audits
  • Leads/supports corrective/preventative actions development relevant to skill area as a result of inspection and audit outcomes (activity is done in partnership with R&D QA).
  • Prepares and/or reviews relevant Jazz controlled documents to ensure alignment and that global PV requirements are met
  • Undertakes additional projects, as assigned, in support of Jazz PQS or other business goals.

Required Knowledge, Skills, and Abilities

  • Knowledge of and experience with FDA and EU PV regulations
  • In depth knowledge of pharmacovigilance activities and processes
  • Knowledge of current and emerging regulatory requirements and expectations including EMA GVP Modules, FDA IND and NDA reporting requirements, global risk management requirements, ICH, CIOMS.
  • Experience in working with business partners/distributors/contractors
  • Excellent teamwork and interpersonal skills are required with proven ability to effectively lead (multiple) projects and teams to successful conclusion
  • Able to perform a variety of complicated tasks with a wide degree of creativity and latitude
  • Must possess excellent communication (oral and written) and problem-solving skills
  • Strong computer skills in Word, Excel, and Power Point

Required/Preferred Education and Licenses

  • Health Care Professional Degree (e.g. RN, BSN, PA, NP, BPharm) or Life Science Degree (e.g. BSc Pharmacology, BSc Biology, BSc Neuroscience, etc.), or equivalent experience required; Postgraduate Degree (PharmD, MSc, strongly desired)
  • B.A/B.S or equivalent experience in a drug safety or clinical environment with a minimum of six (6) years of direct pharmacovigilance experience; or
  • MS/MA degree in related discipline and four (4) years of related experience
  • Equivalent combination of education and experience in Drug Safety and Pharmacovigilance in Biotech/Pharmaceutical industry

Description of Physical Demands

  • Occasional mobility within office environment.
  • Routinely sitting for extended periods of time.
  • Constantly operating a computer, printer, telephone and other similar office machinery.

Description of Work Environment

  • Work indoors in normal office environment with little exposure to excessive noise, dust, fumes, vibrations and temperature changes.
  • Frequent computer use at workstation.
  • May move from one work location to another occasionally.
  • Responsibilities may require a work schedule that may include working outside of “normal” work hours, in order to meet business demands.
  • Occasional public contact requiring appropriate business apparel.

Jazz Pharmaceuticals is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law.

Jazz Pharmaceuticals is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law.

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