Shire Safety Lead in Cambridge, Massachusetts

Primary Duties:

This position is a member of the US Regional Drug Safety Team within Global Drug Safety (GDS). This position supports the RDS team in PV oversight and support of the post-market safety function for the region and may liaise with stakeholders in other functional areas accordingly to ensure that the interests of GDS and the wider ‘system of pharmacovigilance’ are respected. This role will assist in the workflow of the team, maintain knowledge in all locally – marketed Shire products and support AE training needs external to GDS. The Safety Associate will support the handling of sensitive customer issues and is expected to exhibit competency when dealing with internal and external customers.

Responsibilities

  • Escalation contact for enquiries coming into GDS. This may include review of source documents, assessing case priority, company awareness date, need for and request for follow-up and identifying duplicate cases.

  • May participate in literature review activities related to adverse event reporting.

  • Collaborate with relevant counterparts in the regional and country drug safety functions to facilitate the global exchange of safety information.

  • Interface with Internal GDS teams including Safety Operations, Medical Safety and Safety Support.

  • Interface with external departments including Clinical Operations, Regulatory Affairs, QA&C, and other groups (e.g. Commercial, Legal, Marketing, IT, etc.)

Education and Experience Requirements:

Required Degree: Associate’s or Bachelor’s degree for Nursing Bachelor’s degree or Pharm D for Pharmacy

Preferred Degree: Nursing: Bachelor’s degree or Pharmacy: Pharm D

Minimum of 1-2 years experience in pharmaceutical industry

2-3 years of hospital, patient care or equivalent experience

Key Skills, Abilities, and Competencies

  • Strong clinical and medical knowledge base

  • Excellent analytical and problem solving skills

  • Excellent oral and written communications skills

  • Collaborative interpersonal skills to foster team environment

  • Ability to work independently under strict timelines and changing priorities

  • Ability to multitask and prioritize changing workload for self and others on a daily basis

  • Ability to establish priorities for self and others & proceed with objectives

  • Strong knowledge of drug safety database

  • Ability to prioritize workload

  • Adaptable to change

Notice to Employment / Recruitment Agents:

Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire’s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire and only if the candidate is submitted via the Agency Portal. Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration.

Equal Employment Opportunity

Shire is an Equal Opportunity Employer committed to a diverse workforce. Shire will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, national origin, ancestry, age, sexual orientation, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law.

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Pay Transparency Policy - https://www.dol.gov/ofccp/pdf/pay-transp_formattedESQA508c.pdf

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.

Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We strive to develop best-in-class products, many of which are available in more than 100 countries, across core therapeutic areas including Hematology, Immunology, Neuroscience, Ophthalmics, Lysosomal Storage Disorders, Gastrointestinal/Internal Medicine/Endocrine and Hereditary Angioedema; and a growing franchise in Oncology.

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.