Montana Jobs

facebook youtube linkedin
Mobile Montana Labor & Industry Mobile Logo

Job Information

Merck Senior Pharmacovigilance Specialist, Remote based in Helena, Montana

Job Description

Senior Pharmacovigilance (PV) Specialist, PV Business Group, collaborates with company staff to provide PV input for company processes and standards that require adverse event (AE) collection. Maintains PV global standards for relevant activities to ensure compliance and quality of PV requirements. Senior PV Specialist stays current on existing and emerging PV regulations and guidance.

This Position can be based remotely in EDT time zome .

Primary activities:

  • Contribute to, and provide subject matter expertise for PV templates for clinical trial protocols to ensure compliance with global PV regulations

  • Review and approve PV content of clinical trial protocols

  • Participate in interdepartmental and interdivisional meetings in support of individual protocol reviews, input for PV requirements, and related processes

  • Collaborate interdepartmental to ensure PV requirements are incorporated into business processes, standards and resources

  • Provide support and training for relevant topics

  • Process incoming requests from internal and external sources related to PV requirements and initiate appropriate course of action and/or response

  • Maintain relevant PV standards and resources

  • Assist in preparing and responding to Regulatory Agency Inspections as well as internal and external audits as applicable

  • Support any other project or perform any other task deemed appropriate by management

​Qualifications

Education:

  • Bachelor's degree or master's degree in health care or pharmaceutical related field

Required:

  • Candidate is required to have three years of safety experience or related areas such as Clinical Risk Management, Clinical or Regulatory

  • Strong knowledge base of pharmacovigilance principles

  • Excellent communication and interpersonal skills

  • Attention to detail and ability to be flexible in order to meet daily competing priorities of the business

  • Ability to independently manage projects and drive projects to completion

Preferred:

  • Strong knowledge base of pharmacovigilance regulations

  • Demonstrate leadership and proficiency managing across organizations

We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” that great medicines can make a significant impact to our world. 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 .

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.

Residents of Colorado

Click here (https://survey.sogosurvey.com/Survey1.aspx?k=SsQYWYYQsQRsPsPsP&lang=0) to request this role’s pay range.

Current Employees apply HERE (https://wd5.myworkday.com/msd/d/inst/1422$1533/rel-task/3001$14.htmld)

Current Contingent Workers apply HERE (https://wd5.myworkday.com/msd/d/task/1422$4020.htmld)

US and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here (https://survey.sogosurvey.com/r/aCdfqL) if you need an accommodation during the application or hiring process.

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

EEOC Poster (https://www.dol.gov/sites/dolgov/files/ofccp/regs/compliance/posters/pdf/eeopost.pdf)

EEOC GINA Supplement​

OFCCP EEO Supplement (https://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCP_EEO_Supplement_Final_JRF_QA_508c.pdf)

Pay Transparency Nondiscrimination

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:

No Travel Required

Flexible Work Arrangements:

Remote Work, Telecommuting

Shift:

1st - Day

Valid Driving License:

Yes

Hazardous Material(s):

Number of Openings:

1

Requisition ID: R130148

DirectEmployers