Requisition ID: DRU000945
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 its legacy for over a century. Merck's success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.
Merck is on a quest for cures and is committed to being the world's premier, most research-intensive biopharmaceutical company. Today, we're doubling down on this goal. Merck Research Laboratories is a true scientific research facility of tomorrow, and will take Merck's leading discovery capabilities and world-class small molecule and biologics R&D expertise to create breakthrough science that radically changes the way we approach serious diseases.
Summary of the Job:
The Pharmacovigilance Manager oversees a team of PV Technicians (Merck employees and possibly contractors) managing the day to day activities of the PV Call Center. This position may also serve as the pharmacovigilance liaison to the Global Quality group and Global Pharmacovigilance group.
Key responsibilities may include, but are not limited to:
• Manage the day to day activities of the PV Call center, including overseeing a team of veterinary technicians (Merck employees and possibly contractors) successfully logging product complaints and adverse events, associated with the Companion Animal portfolio. Determine appropriate staffing needs for the Call Center, conduct annual performance appraisals and handling other supervisory responsibilities.
• Train staff (e.g. PV Techs and Quality Assurance colleagues) on PV procedures, SOP's and proper data entry and use of the database.
• May work with the systems administrator for the PV Works database, liaising with IT to ensure the needs of the Pharmacovigilance Department are met. Initiate requests for system upgrades to the database and assist with UAT scripts for the changes. Troubleshoot problems and recommend solutions. Participate on Global PV Works committees related to system upgrades.
• Maintain the product dictionary and update authorized users in the PV Works database.
• Generate and circulate analysis reports for the Companion Animal Business Unit. Provide data to the pharmacovigilance veterinarians for the generation of the quarterly review reports. Provide detailed reports to Marketing as needed.
• Monitor the complaint database (PV Works) and review/release cases to Global PV according to internal timelines to maintain compliance. Provide feedback to case owners as needed.
• Liaise with Global Quality on product quality issues and reporting and with Global PV regarding product complaints and releasing comments.
Scope and Context:
This position is a team leader and individual contributor with the ability to motivate others and maintain the integrity of the information in the pharmacovigilance database. Oversees a team of direct reports logging in excess of 20,000 complaints per year. Maintains office at the Madison, NJ headquarters location.
Animal Health Commercial Competencies:
• Demonstrate Ethics & Integrity
• Drive Results
• Focus on Customers & Patients
• Make Rapid Disciplined Decisions
• Act with Courage & Candor
• Build Talent
• Foster Collaboration
• Business & Financial Acumen
• Working Across Boundaries
• Strategic Thinking • Project Management
• Productive Communication
• Problem Solving
Core Commercial Functional Competencies
• Customer and Market Insights
• Strategic Business Management
• Product Knowledge & Portfolio Management
• Account Management
• Customer Engagement
• Market Access
• Regulatory & Compliance Knowledge
• Lifecycle Management
Education Minimum Requirement:
• Bachelor's degree in Veterinary Technology, Animal Science, Biology, Chemistry, or related field. A degree in Information Technology will also be considered.
Required Experience and Skills**:
• Requires a minimum of 3 years' experience in technical service support for a veterinary pharmaceutical, biological or nutritional company. Information technology experience is a plus.
• Requires 3 years related experience as a veterinary technician or applicable work in a private veterinary practice.
Strong leadership ability to coordinate the activities of the Call Center
• Ability to manage resources effectively
• Strong collaboration skills and ability to successfully partner cross functionally with Global Quality, Marketing, IT and Global PV colleagues
• Must have excellent written and verbal communication skills.
• Must have strong working knowledge of PV-Works database and the ability to read and comprehend government regulations on pharmacovigilance.
Your role at Merck is integral to helping the world meet new breakthroughs that affect generations to come, and we're counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At Merck, we're 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 email@example.com .
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.
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Merck is an equal opportunity employer, Minority/Female/Disability/Veteran - proudly embracing diversity in all of it's manifestations.
Job: Drug/Dvcs Sfty Survnce (NonMD)
Employee Status: Regular
Travel: Yes, 5 % of the Time
Number of Openings: 1
Shift (if applicable): 1st
Company Trade Name: Merck
Nearest Major Market: New Jersey