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Pharmacovigilance Compliance Coordinator

Merck & Company

Pharmacovigilance Compliance Coordinator

Madison, NJ
Full Time
Paid
  • Responsibilities

    Pharmacovigilance Compliance Coordinator Date:Jan 3, 2019 Location:Madison, NJ, US -Requisition ID:DRU000932 Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where Merck has codified itslegacy for over a century. Mercks success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare. Regulatory & Compliance Responsibilities 50% -Processing adverse event, product quality and human exposure complaints for regulated products in compliance with Global Pharmacovigilance requirements. -Reviewing and releasing PV Works cases to ensure timelines are met for submission to Global Pharmacovigilance. -Maintaining and updating work instructions, policies and procedures for PV department. -Assist with trend analysis, compliance reports and data mining as needed. Telephone Support & Triage for Technical Inquiries and Complaint Handling 20% -Handling phone calls to the Technical Services 800-line, faxes, written correspondence, e-mail and website inquiries from veterinarians, pet owners, MAH and distributor sales representatives and breeders regarding questions pertaining to on-label product indications and usage and competitor product comparisons. -Handling and processing all complaints not requiring veterinary intervention, including product quality complaints and selected categories of efficacy and adverse reaction complaints. -Identifying trends and initiating product testing procedures to help resolve product complaints. -Tracking all complaints requiring product testing through Global Quality and following up with the customer. -Retrieving, processing and following-up on all product complaints submitted by our after-hours agencies. -Assisting pharmacovigilance veterinarians in processing and following through on product complaints, including -Correspondence with customers/pet owners. -Uploading correspondence/medical records into the complaint database. -Reviewing medical records for accuracy and forwarding to PV Veterinarians. -Reviewing compensation requests. -Processing check requests. -Contacting complainants for follow-up and updating the complaint database. Quality Assurance associated with Product Complaints 15% -Serving as the primary contact for product quality issues, product testing procedures and warranty issues. -When appropriate, initiating the return of product samples from the field for quality assurance testing, ensuring timely return of the product, forwarding samples to Global Quality and initiating return of samples for destruction when appropriate. -Uploading quality assurance testing results into the complaint database and following up with the complainant. Marketing and Sales Responsibilities 5% -Representing Merck Animal Health at veterinary conventions or meetings. -Attend continuing education seminars at veterinary conventions and share that information with intra- and interdepartmental MAH personnel. -Contacting sales representatives on potential sales leads. -Notifying marketing managers/directors when receiving feedback on MAH or competitive product information or trends in the veterinary marketplace. Miscellaneous Responsibilities 10% -Manage or assist with special projects, such as diagnostic testing programs when assigned. -Assist with training the PV department on compliance requirements and product knowledge. -Provide support to sales training when requested. -Provide administrative or training support at meetings or national sales meetings.Qualifications Education Minimum Requirement Bachelors degree (Animal Science, Biology, or other Science degrees preferred); Advanced degree preferred Required Experience and Skills -Minimum 3 years PV experience. -Advanced veterinary product knowledge -Demonstrated leadership ability. -Advanced competency with complaint databases, regulatory and corporate compliance procedures. Preferred Experience and Skills -Past experience as a veterinary technician preferred. -Experience working for an animal health manufacturer preferred. Your role at Merck is integral to helping the world meet new breakthroughs that affect generations to come, and were counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At Merck, were inventing for life. If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to -. Search Firm Representatives Please Read Carefully Merck & Co., Inc. is not accepting unsolicited assistance from search firms for this employment opportunity. Please, no phone calls or emails. All resumes submitted by search firms to any employee at Merck via email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of Merck. No fee will be paid in the event the candidate is hired by Merck as a result of the referral or through other means. Visa sponsorship is not available for this position. For more information about personal rights under Equal Employment Opportunity, visit: -Merck is an equal opportunity employer, Minority/Female/Disability/Veteran proudly embracing diversity in all of its manifestations. Job:Drug/Dvcs Sfty Survnce (NonMD) Other Locations: Employee Status:Regular Travel:Yes, 5 % of the Time Number of Openings:1 Shift (if applicable): Hazardous Materials:None Company Trade Name:Merck Nearest Major Market:New Jersey

  • Industry
    Manufacturing