Pharmacovigilance
Specialist
Allegan, Michigan

About Perrigo

Perrigo Company is a leading global
healthcare supplier that develops, manufactures and distributes over-the-counter
(OTC) and prescription pharmaceuticals (Rx), nutritional products, active
pharmaceutical ingredients (API) and consumer products. Perrigo Company
is the world's largest manufacturer of OTC pharmaceutical products for
the store brand market with over $2 billion in annual sales. The Company's
primary markets and locations of manufacturing facilities are the United
States, Israel, Mexico and the United Kingdom.

Perrigo produces more than 44 billion
tablets annually, is the largest producer of liquid antacid and the
second largest producer of acetaminophen and ibuprofen. Perrigo has
more OTC ANDA approvals (61) than any other company (including branded
companies).

Description:

Reporting to the Director of Pharmacovigilance
and Consumer Affairs, this position will be responsible for receiving
and evaluating adverse drug experience and/or product complaints on
OTC and prescription products. Responsibilities include, but are not
limited to:

• Perform follow up with consumers
  and healthcare professionals for the purpose of completing case documentation.
• Interact with Consumer Affairs
  department on the quality related investigations of adverse events,
  when appropriate.
• Assist international sites
  with preparation and review of adverse event reports.
• Interact with Perrigo license
  partners to exchange required safety data.
• Interact with Regulatory
  Affairs for Annual Reporting, labeling, and other product related issues.
• Prepare and review FDA MedWatch,
  ICH CIOMS forms, and other required regulatory reporting forms
• Coding of adverse event terms
  in MedDRA.
• Prepare and/or review quarterly
  and annual safety reports for submission to the FDA.
• Assure data accuracy, clinically
  valid case assessment, and regulatory reporting status assessment.
• Identify and process serious
  or expedited reports for evaluation and reporting.
• Assist call center personnel
  in responding to medical inquiries and prepare written responses to
  complaints.
• Assist with searches and
  interpretation of scientific literature for adverse event reports.
• Assist Legal Department when
  requested with specific searches and evaluation.
• Carry out all responsibilities
  in accordance with Perrigo policies and procedures, as well as federal,
  state, and local laws in all countries that Perrigo conducts business.
• Perform other related duties
  and assist with special projects as assigned.

Qualifications:

Bachelor’s Degree in the medical field
or life sciences required; Pharmacy or Nursing highly preferred. Minimum
of 5 years experience in clinical practice and/or the pharmaceutical
industry required. Excellent written and oral communication skills are
required. Proficient with Microsoft Office Tools and the ability to
learn computer applications used for collecting and processing adverse
events and product complaints are required. Ability to read, understand,
and apply U.S. and international law and regulatory guidance documents
to job function are required. Must be able to work under pressure with
minimal supervision and deal effectively with confidential information.
This position includes interaction with the public and requires the
ability to handle sensitive and stressful situations appropriately.
Knowledge of Perrigo products and their therapeutic uses preferred.
Previous experience with medical coding or adverse event reporting highly
preferred. Working knowledge of FDA/EU/International regulations governing
Adverse Event collection and reporting highly preferred.

Qualified applicants
are requested to apply online at www.perrigo.jobs, under
‘US Careers.’ For specific questions about the position, contact
Hillary DeBoer at (269) 686-3331 or hillary.deboer@perrigo.com

Perrigo Company is
an Equal Opportunity Employer.