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Merck Associate Principal Scientist, Drug Safety in Jackson, Mississippi

Job Description

Supports the Clinical Safety and Risk Management (CSRM) team in the safety surveillance of assigned products. Proficient in retrieval, data preparation, and preliminary analysis for, and quality assurance of, prepared responses to inquiries from health professionals, regulatory agencies and other customers regarding adverse experiences reported with our Company's products. This includes the authoring of PSURs and other regulatory documents. With guidance from CSRM team assists with the safety surveillance review of adverse experience (AE) reports and with the development and evaluation of risk management plans (RMPs). Functional area expert with primary ownership of designated CSRM programs.

Primary activities include, but are not limited to:

  • Advanced knowledge of safety surveillance/pharmacovigilance and epidemiologic principles to complete the following activities

  • Periodic review of AE reports in support of Adverse Experience Review (AER) process including presentation of safety data to the Risk management Safety Team ( RMST)

  • Prepares data for retrieval and analysis which may include querying the safety surveillance databases, preparing spreadsheets for interpretation and review of data output.

  • With CSRM team, independently author agency responses and regulatory documents such as PSURs

  • Independently respond to requests posed by internal customer

  • Collaborates with the CSRM team in the authoring of agency responses and regulatory documents such as PSURs, RMPs and the Clinical Overviews. Conducts literature reviews, identify background population rates and summarize relevant findings to support the regulatory responses and PSURs.

  • Facilitate the submission process for regulatory documents and publications.

  • Lead the quality assurance of prepared responses to inquiries from health professionals, regulatory agencies and other customers regarding adverse experiences reported with our Company's marketed products

  • Mentor scientists and advanced scientists in the label validation process.

  • In conjunction with the CSRM team, work to obtain information to further clarify AE reports received. This could include, but is not limited to, classification of reports and follow-up phone calls for AEs of special interest.

  • Independently able to utilize pharmacovigilance computer software programs to assist with data capture

  • Manage programs and registries with primary ownership including the monitoring and follow-up of reports in special programs such as pregnancy registries and/or viral identification programs

  • Serve as a functional area representative, providing oversight, management and presentation of program data such as pregnancy registries and/or viral identification programs with primary ownership. Manage outside contracts for such programs and/or consultants. Attend periodic program meetings, reporting issues to CSRM physician/management.

  • Assist with manuscripts for submission to peer reviewed journals, poster and /or oral presentations on the safety profile of assigned products and the guidance of such presentations through the internal clearance process.

Skills:

  • Bachelor’s degree in nursing, pharmacy or other relevant health field is required and 9 years of professional experience that includes both clinical and pharmaceutical experience. The pharmaceutical experience should include a minimum of 5 years of relevant Pharmacovigilance experience in the review of aggregate safety data and authoring of safety documents.

OR

  • Bachelor’s degree in nursing, pharmacy or relevant health field is required with a relevant masters degree and 7 years professional experience that includes both clinical and pharmaceutical experience . The pharmaceutical experience should include a minimum of 5 years of relevant Pharmacovigilance experience in the review of aggregate safety data and authoring of safety documents.

  • This position requires demonstrated leadership skills, independent programmatic support, excellent writing and verbal communication skills, problem solving ability and analytical skills. Proficiency with Microsoft program package is required with data management quality assurance and compliance experience is required.

We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” and that great medicines can make a significant impact to our world. And we believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.

Who we are …

We are known as Merck & Co., Inc., Kenilworth, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.

What we look for …

In a world of rapid innovation, we seek brave Inventors who want to make an Impact in all aspects of our business, enabling breakthroughs that will affect generations to come. We encourage you to bring your disruptive thinking, collaborative spirit and diverse perspective to our organization. Together we will continue Inventing For Life, Impacting Lives while Inspiring Your Career Growth .

Invent. Impact. Inspire.

NOTICE FOR INTERNAL APPLICANTS

In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.

If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.

We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.

Residents of Colorado

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We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.

Search Firm Representatives Please Read Carefully

Merck & Co., Inc., Kenilworth, NJ, USA, also known as Merck Sharp & Dohme Corp., Kenilworth, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status:

Regular

Relocation:

No relocation

VISA Sponsorship:

No

Travel Requirements:

10%

Flexible Work Arrangements:

Flex Time, Remote Work, Telecommuting

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings:

1

Requisition ID: R110617

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