Our Regulatory Affairs team bring new medical advancements to the world by facilitating communications and procedures that allow swift, organized compliance across regulatory agencies. We are an international network on the leading-edge of healthcare breakthroughs that help provide new, reliable, and compliant medical products, practices and solutions to the world.
Due to Covid restrictions, this position is currently remote
Performs primary medical review of serious adverse experience reports and other Adverse Event (AE reports) of interest to monitor and describes the safety profile of assigned products; taking a dynamic role in the oversight and development of pharmacovigilance and risk management plans under the overall direction of the CSRM physician/senior management. Leads preparation regulatory documents and responses to inquiries from health professionals and regulatory agencies regarding adverse experiences reported for company marketed products; strategizes with safety team recommending appropriate data to respond to queries and analyze data.
Primary activities include, but are not limited to:
In conjunction with the CSRM physician/management, works to expand and apply clinical, pharmacological, and epidemiologic knowledge and information technology skills to managing the safety surveillance for assigned products.
Accountable for overall safety profile of assigned products including information from registries and special programs.
Performs safety surveillance review of adverse experience reports as per Standard Operating Procedure with the CSRM physician/management in order to assist with the monitoring and description of the safety profile of assigned products and to identify and respond to safety issues.
Works with CSRM physician/management to select and analyze the appropriate data from IT systems in order to investigate safety issues.
Working with the safety team to delegate appropriate activates related to Pharmacovigilance to the scientists and providing medical input as warranted.
Prepares responses to safety inquiries from health care professionals, regulatory agencies, subsidiary staff, and other internal customers in conjunction with the Clinical Research Management (CRM) physician/management assigned to the product.
Advanced Pharmacovigilance and Risk Management Plans knowledge and strong mentoring skills to educate stakeholders outside of CSRM and less experienced CSRM staff.
Develops working knowledge of pharmacovigilance and Risk Management Plans; begins to educate stakeholders outside or CSRM about risk management and the role of CSRM.
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 medical associates and, core member of Risk Management Safety Team (RMST).
Represents CSRM on cross-functional teams and committees as appropriate.
Assists the CSRM physician/management with the development and evaluation of Risk Management Plans (RMP) and Risk Evaluation and Mitigation Strategies (REMS) for assigned products.
Lead communication and informational efforts to product teams regarding safety evaluation and risk management throughout clinical, submission and post-marketing phases.
Participates in the development, implementation, and evaluation of standards, processes, metrics and other department initiatives. Assists in the preparation of manuscripts for submission to peer-reviewed journals and gives poster and oral presentations at medical conferences on the safety profile of assigned products.
Assists with the guidance of these documents through the internal clearance and external submission process.
Undergraduate in nursing (BSN), pharmacy, Physician's Assistant, or other relevant clinical health-related field AND Graduate degree in a relevant health-related field OR
Graduate degree in nursing (MSN), PharmD, Physician's Assistant, or other relevant clinical health-related field (undergraduate training is flexible with advanced education in a medical discipline)
Skills & Experience
Clinically relevant medical experience in the undergraduate or graduate program is essential (e.g. nursing, pharm D, PA, or other relevant clinical health-related field).
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., Rahway, 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 ...
Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us-and start making your impact today.
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.
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New hires in office-based roles in the US & Puerto Rico will be required, subject to applicable law, to demonstrate that they have been fully vaccinated for COVID-19 or qualify for a medical or religious exemption to this vaccination requirement that can be accommodated without an undue burden to the operation. However, subject to applicable law, employees working in roles that the Company determines require routine collaboration with external stakeholders, such as employees in health services, customer facing commercial, or research based roles, will be required to be fully vaccinated as a condition of employment.
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Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, 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.
Flexible Work Arrangements:
Flex Time, Remote Work, Telecommuting
Valid Driving License:
Number of Openings:
Requisition ID: R195218