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Senior Specialist Global Pharmacovigilance - Training

Expired Job

Merck & Co., Inc. Madison , NJ 07940

Posted 3 months ago

Requisition ID: DRU000816

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's Animal Health (MAH) Division works to improve the health of animals around the world through collaborative partnerships and a deep sense of responsibility towards our customers, consumers, animals, society, and planet. This team of energetic, independent thinkers offers one of the industry's most innovative portfolios of products, services, and technologies that serve to prevent, treat, and control diseases across all major farm and companion animal species both domestically and internationally.

  • Establish and maintain an effective and indepth pharmacovigilance (PV) training program for national and regional affiliates.

  • Deliver face-to -face training for national and regional PV teams worldwide for existing regulations/policies and procedures.

  • Create recorded instructor-lead training.

  • Design and develop training materials.

  • Track training and training records.

  • Perform project management and logistics for face-to-face training meetings.

Qualifications

Education Minimum Requirements:

  • BS or equivalent
Required Experience and

Skills:
  • A minimum of 7 years of experience in the pharmaceutical industry

  • Working knowledge of pharmacovigilance and associated quality management system

  • Strong working knowledge of major pharmacovigilance regulations and procedures ( e.g., EMA, FDA,(V) ICH)

  • Familiarity with global safety database

  • Familiarity with learning management systems

  • Well-developed presentation skills, proficiency in PPT

  • Excellent interpersonal skills with demonstrated ability to gain the cooperation and support of others; ability to lead by example and foster collaborative relationships

  • Must be able to travel 35-50%, domestic and internationally

Preferred Experience and

Skills:
  • 4 years experience developing / facilitating / delivering learning solutions

  • Experience in assessing competency gaps and identifying what people need to learn for successful individual and organizational performance

  • Project management experience

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 staffingaadar@merck.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.

For more information about personal rights under Equal Employment Opportunity, visit:

EEOC Poster

EEOC GINA Supplement

Job: Drug/Dvcs Sfty Survnce (NonMD)

Other Locations:

Employee Status: Regular

Travel: Yes, 50 % of the Time

Number of Openings: 1

Shift (if applicable): 1st

Hazardous Materials: NO

Company Trade Name: Merck

Nearest Major Market: New Jersey


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VIEW JOBS 11/2/2018 12:00:00 AM 2019-01-31T00:00 Requisition ID: DRU000914 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's Animal Health (MAH) Division works to improve the health of animals around the world through collaborative partnerships and a deep sense of responsibility towards our customers, consumers, animals, society, and planet. This team of energetic, independent thinkers offers one of the industry's most innovative portfolios of products, services, and technologies that serve to prevent, treat, and control diseases across all major farm and companion animal species both domestically and internationally. The responsibilities for this position include but are not limited to: * Review and approve adverse event reports for pharmaceutical, biological and pesticide animal health products. * Determine case validity and enter into validated database as appropriate. Submit expedited cases to the appropriate Health Authority. * Process and/or submit Aggregate reports. * Initiate and coordinate investigations into pharmacovigilance reports. * Provide guidance to national pharmacovigilance teams regarding cases. * May perform trending and signal detection as appropriate. * Serve on internal teams to develop and implement procedures to ensure regulatory compliance is maintained. * Assist in processing and case administration tasks. Qualifications Education Minimum Requirement: * DVM/VMD or equivalent Required Experience and Skills: * Clinical veterinary medical experience. * Excellent interpersonal, communication and negotiating skills. * Must be able to work effectively as a team member in a highly interactive and collaborative environment. Preferred Experience and Skills: * Knowledge of animal health regulations of major regulatory agencies (FDA, EPA, USDA, and/or EMA). * Experience with Microsoft Office. * Strong organizational, written and oral skills. * Ability to manage several projects simultaneously strongly desired. * At least 2 years of experience in Pharmacovigilance or Regulatory Affairs in an industrial setting is an advantage. 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 staffingaadar@merck.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. For more information about personal rights under Equal Employment Opportunity, visit: EEOC Poster EEOC GINA Supplement OFCCP EEO Supplement 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) Other Locations: Employee Status: Regular Travel: Yes, 5 % of the Time Number of Openings: 1 Shift (if applicable): 1st Hazardous Materials: Company Trade Name: Merck Nearest Major Market: New Jersey Merck & Co., Inc. Madison NJ

Senior Specialist Global Pharmacovigilance - Training

Expired Job

Merck & Co., Inc.