Sr. Spclst, Drug Safety Job

Employer
Merck
Location
Gwynedd, PA, US
Posted
October 09 2017
Discipline
Other
Organization Type
Pharma
Sr. Spclst, Drug Safety-DRU000694

Description

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.

Senior Pharmacovigilance Specialist performs those activities essential to ensuring the quality and compliance of adverse experience information. Senior PV Specialist stays current on existing and emerging regulations and guidances pertaining to pharmacovigilance. On a continual basis, actively works to incorporate operational excellence principles into processes related to adverse experience processing and management to ensure optimal compliance.

Primacy Activities include but are not limited to:

- Performs unblinding of clinical trial cases and liaises with key cross functional areas (Clinical, Risk Management, and Regulatory) to ensure accurate and timely submission of 7 and 15 day expedites to global Health Authorities.
- Performs compliance monitoring activities for expedited individual case submissions to regulatory agencies. Performs detailed investigations for late submissions and liaises with appropriate business parties as appropriate.
- Performs compliance monitoring activities specific to Business Partners. Maintains working knowledge of licensing agreements and tracks and monitors reports sent late to agencies as a result of late partner adverse experience (AE) information exchanges. Monitors Partners’ compliance to the agreements and compiles metrics which are provided to Partners on a monthly basis.
- Ensures robust documentation of root cause and corrective and preventative actions (CAPAs) for late reports to regulatory agencies as well as late reporting by Partners to Merck per agreement timeframes
- Compiles compliance metrics for review by Senior Management and Case Processing Providers.
- Provides expert guidance to case processing providers' areas on policies and procedures governing the processing of adverse experience information.
- Works with Senior Management and Documentation Unit to identify and prioritize requirements for new and updated sections of User Manual, Standard Operating Procedures, and training material in relation to new and/or improved business processes and evolving worldwide regulatory requirements.
- Performs quality review of a sampling of adverse experience reports to ensure adherence to global case processing standards. Identifies, prioritizes, and monitors quality issues to be resolved to maintain compliance.
- Compiles quality metrics for review by Case Processing Providers and Senior Management.
- Reviews study protocols and AE monitoring plans for AE requirements and liaises with business partners to ensure compliance.

Qualifications

Education:

- Bachelor's degree or Master's degree in health care/pharmaceutical related field or project management.

Required:

- Three years of safety experience or related areas such as Clinical Risk Management, Clinical or Regulatory.

Preferred:

- Strong knowledge base of pharmacovigilance principles with close attention to detail and ability to be flexible in order to meet daily competing priorities of the business.
- Candidate should be extremely organized with strong documentation and analytic skills.
- Demonstrates leadership, and excellent communication and interpersonal skills.
- Ability to project manage and independently drive projects to completion.
- Strong knowledge of and experience with advanced MS Excel and Access.

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 an accommodation for the application process please email us at 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.

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

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EEOC GINA Supplement​



Merck is an equal opportunity employer, Minority/Female/Disability/Veteran – proudly embracing diversity in all of its manifestations.


Job: Drug/Dvcs Sfty Survnce (NonMD)

Job Title:Sr. Spclst, Drug Safety

Primary Location: NA-US-PA-Upper Gwynedd

Employee Status: Regular

Travel: No

Number of Openings: 2

Company Trade Name:Merck

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