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Pharmacovigilance Scientist / Senior Pharmacovigilance Scientist

Takeda Pharmaceuticals

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Location: Chicago, IL Posted Date: 5/6/2013 Position Type: Full time Job Code: 1300280 Required Education: Bachelors Degree

Description

Please note that the requirements specified in this posting are the basic qualifications required for the Pharmacovigilance Scientist position; however, job title will be dependent on the candidate's level of experience in those requirements.

OBJECTIVE:

* Provide therapeutic area PV expertise support for assigned developmental and/or marketed products (small scope projects or part of a large scope project) in conjunction with pharmacovigilance physicians
* Represent pharmacovigilance department internally and externally (either permanently or as a backup to a senior PV scientist) at a global level and to function as an authoritative and professional member of relevant teams.
* Contribute to signal evaluation/safety monitoring activities
* Contribute and assist in pharmacovigilance activities including benefit/risk and regulatory activities and interactions

ACCOUNTABILITIES:

* In depth knowledge and understanding of designated products/studies.
* Represent pharmacovigilance department (either permanently or as a backup to a senior PV scientist) in cross-functional teams or committees and external environments that have product or therapeutic area impact.
* Review and provide PV therapeutic area expertise for development of protocols, IBs, SAPs, CSRs and other relevant project/study
* Participate in evaluation of safety issues
* Write and/or review aggregate reports, e.g., PSURs; DSURs.
* Write and/or review PV sections of regulatory submissions, e.g., NDA, MAA and regulatory responses. collaborating with PV physicians and other GST members.
* Write and/or review of monthly safety signal reports
* In conjunction with pharmacovigilance physicians write and maintain Risk Management Plans. Contribute to the oversight and monitoring of effectiveness of the RMP.
* Participate in Global Safety Teams, coordinating all aspects of signal evaluation/safety review activities.
* Assist with writing and maintenance of the Safety Monitoring Plan
* Contribute to safety summaries to support changes to the PI/SmPC, Type II variations including drafting justification documents
* Assist in the internal and external dissemination of important new safety information or actions (e.g. DHCP letters)
* Provision of information to EU QPPV office for product oversight.
* Liaise with marketing team(s) to evaluate safety impact and provide input into program design (e.g., social media, market research, patient support programs).
* Contribute to improvement of departmental processes
* Any other tasks assigned by manager to assist in departmental activities

Requirements

Please note that the requirements specified in this posting are the basic qualifications required for the Pharmacovigilance Scientist position; however, job title will be dependent on the candidate's level of experience in those requirements.

EDUCATION, EXPERIENCE AND SKILLS:

* Registered nurse or Bachelors degree in medical field preferred
* Minimum 5 years of experience in healthcare, clinical or pharmacovigilance related.
* High level of proficiency in computer literacy with Microsoft applications.
* Excellent self-motivated and self-directed organizational  and prioritization ability
* Excellent written and oral communication skills including experience with presenting to large groups.
* Demonstrated excellent interpersonal, communication, and team-working skills.

PHYSICAL DEMANDS:

* Routine demands of an office-based environment.

TRAVEL REQUIREMENTS:

* Estimated 5-10 times per year including possible international travel.

We are driven to improve people's lives.

www.takedajobs.com

We are an equal opportunity employer.
No Phone Calls or Recruiters Please.
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