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Safety & International Lead, R&D QA&Compliance 8/30/2016

Shire Pharmaceutical Cambridge, MA

Company
Shire Pharmaceutical
Job Classification
Full Time
Company Ref #
14387BR
AJE Ref #
576017924
Location
Cambridge, MA
Experience
Mid-Career (2 - 15 years)
Job Type
Regular
Education
Bachelors Degree

JOB DESCRIPTION

Job Description
PRIMARY ROLE:
Under the direction of the Head of Global Safety & International R&D QA&C, this position is responsible for the oversight and conduct of audits in support of the pharmacovigilance system audit plan. The purpose of the role is to provide ongoing assessment and support of safety and risk management activities governed by global and local pharmacovigilance regulations.

RESPONSIBILITIES:
80%: EXECUTION OF PHARMACOVIGILANCE SYSTEM AUDIT PLAN
Manage and conduct audit activities associated with pharmacovigilance and clinical trial safety. Ensures the appropriate corrective and preventative actions are completed in a timely manner. Identifies any potential systemic gaps raises to management and assists with the implementation of remediation. Audits include but are not limited to internal systems/processes, vendors, licensing/distribution partners and Local Operating Companies.

10%: COMPLIANCE SUPPORT
Under the direction of the Head of Global Safety & International R&D QA&C, serves in an advisory/consultative capacity in compliance related safety matters. Provides support to Pharmacovigilance (PVRM) in implementing corrective and preventive actions. Works with other R&D QA&C functional areas to perform root cause analysis of safety related compliance issues. Participates in metrics and trending activities in collaboration with the Quality Operations group.

10%: REGULATORY AGENCY SUPPORT
Supports the activities of the preparation, hosting and responses to regulatory agency inspections for pharmacovigilance-related inspections.

EDUCATION & EXPERIENCE REQUIREMENTS:
Bachelor s degree in a life science required;
At least 7 plus years experience in Pharmaceutical research experience including auditing experience especially in pharmacovigilance audits
Knowledge and/or awareness of all applicable regulations and guidances related to global and regional/local pharmacovigilance requirements.

OTHER JOB REQUIREMENTS:
Domestic and international travel required.
Travel for audits and training (up to 30% of the time).
Travel for departmental meetings (up to 5% of the time).

ABOUT SHIRE:
Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We have best-in-class products available in more than 100 countries across core therapeutic areas including Hematology, Immunology, Neuroscience, Lysosomal Storage Disorders, Gastrointestinal / Internal Medicine / Endocrine and Hereditary Angioedema; a growing franchise in Oncology; and an emerging, innovative pipeline in Ophthalmics.

Our employees come to work every day with a shared mission: to develop and deliver breakthrough therapies for the hundreds of millions of people in the world affected by rare diseases and other high-need conditions, and who lack effective therapies to live their lives to the fullest.

EQUAL EMPLOYMENT OPPORTUNITY
Shire is an equal opportunity employer. Shire evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

EEO is the Law
EEO is the Law - Supplement
Pay Transparency Policy

Reasonable Accommodations
Shire is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please call 484-595-8400 and let us know the nature of your request and your contact information.