Merck Hiring for Clinical Safety & Risk Management Sr Medical Associate at Salem, Oregon Full Time

Job Description

Subject to applicable law, all prospective hires will be required to demonstrate that they have been fully vaccinated for COVID-19 or intend to be vaccinated for COVID-19 by November 1, 2021, or qualify for a medical or religious accommodation to this vaccination requirement. Hired candidates who are not vaccinated by November 1, 2021, and who have not been approved for a legally-required medical or religious accommodation will be subject to disciplinary action up to and including termination of employment, subject to applicable law.

Essential function(s) includes, but is not limited to:

Performs primary medical review of serious adverse experience reports and other AE reports of interest to monitor and describes the safety profile of assigned products; takes an active role in the oversight and development of pharmacovigilance and risk management plans under the overall direction of the CSRM team. Leads preparation of regulatory documents and responses to inquiries from health professionals and regulatory agencies regarding adverse experiences reported for our company’s marketed products; strategizes with safety team recommending appropriate data to respond to queries and analyze data.

Primary activities include, but are not limited to:

• Independently working to expand and apply clinical, pharmacological, and epidemiologic knowledge and information technology skills to managing the safety surveillance for assigned products in consultation with CSRM physician.

• Accountable for overall safety profile of assigned products including information from registries and special programs.

• Autonomously performing safety surveillance review of adverse experience reports as per SOP with the CSRM team to monitor and describe the safety profile of assigned products and to identify and respond to safety issues.

• Works with CSRM team to select and analyze the appropriate data from IT systems in order to investigate safety issues.

• Working with the safety team to delegate appropriate activities related to pharmacovigilance to the CSRM scientists and providing medical input as warranted.

• Managing and preparing strategy for regulatory documents and responses to safety inquiries from health care professionals, regulatory agencies, subsidiary staff and other internal customers in conjunction with the CSRM team assigned to the product.

• Advanced pharmacovigilance and risk management plan knowledge and strong mentoring skills to educate stakeholders outside of CSRM and less experienced CSRM staff.

• Applies knowledge of safety profiles along with summary and analysis of safety related data in the regulatory documents such as Periodic Safety Update Reports (PSUR), Developmental Safety Update Reports (DSURs) and summaries in support of regulatory filings.

• Mentoring and providing guidance to the CSRM scientists and CSRM staff.

• Assists the CSRM physician in leading project team and committees as appropriate. Advanced skill in developing and evaluating Risk Management Plans (RMP) and Risk Evaluation and Mitigation Strategies (REMS) for assigned products in consultation with the CSRM physician.

• Lead communication and informational efforts to product teams regarding safety evaluation and risk management throughout clinical, submission and post-marketing phases.

• With minimal guidance, prepares manuscripts for submission to peer-reviewed journals; may give poster and/or oral presentations on the safety profiles of assigned products at medical conferences. Assists with the guidance of such publications through the internal clearance and external submission processes.

• Strong leadership skills and subject matter expertise in specific departmental programs, SOPs, and departmental initiatives.

Skills:

Undergraduate degree in nursing (BSN), pharmacy, Physician’s Assistant, or other relevant clinical health related field AND Graduate degree in a relevant health related field. e.g. Graduate degree in nursing (e.g MSN), PharmD, Physician’s Assistant, or other relevant clinical health related field (undergraduate training is flexible with advance degree in medical discipline).

6-8 years of professional experience with both clinical and pharmaceutical industry experience required, of which a minimum of 3 years MUST include safety experience .e.g. PV or clinical) involving analysis of aggregate safety data and authoring of safety documents.

Excellent writing and communication skills a must. Experience in data analysis or the interpretation of adverse experience information is a plus. Demonstrated leadership skills in managing programs, processes, and facilitating meetings. Problem solving and critical thinking skills.

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.

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

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EEOC GINA Supplement​

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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:

10%

Flexible Work Arrangements:

Flex Time, Remote Work, Telecommuting

Shift:

1st – Day

Valid Driving License:

Hazardous Material(s):

Number of Openings:

1

Requisition ID: R147339