Organon - Senior Scientist, Drug Safety, General Medicine (Remote)

Job Description

P

Secondary Language(s) Job Description

We are seeking candidates with an entrepreneurial and learning spirit who are interested in a career of purpose, personal growth and leadership.

Works in conjunction with the CSRM team in the safety surveillance of assigned products. Performs data retrieval and preliminary analysis for responses to inquiries from health professionals, regulatory agencies and other customers regarding adverse experiences reported. Medical review of serious adverse experience reports and other AE reports of interest to monitor and describe the safety profile of assigned products. Takes an active role in the oversight and development of pharmacovigilance and risk management plans with direction/guidance from the CSRM Team. Assists the CSRM team to author regulatory documents and strategizes recommending appropriate data to respond to queries and analyze data.

Position can be based remotely.

Primary Responsibilities:

Strong working knowledge... and understanding of safety surveillance/pharmacovigilance and epidemiologic principles, assisting the CSRM team with the following activities:

• Periodic review of adverse experience (AE) reports in support of the Adverse Experience Review (AER) process including presentation of safety data to the Risk management Safety Team (RMST). Prepares data for retrieval and analysis. This may include querying the safety surveillance database, interpretation and review of data output.
• With CSRM Team, authoring of agency responses and regulatory documents such as Periodic Safety Update Reports (PSURs), Risk Management Plans (RMPs), Clinical Overview, agency responses.
• Works with CSRM team to select and analyze the appropriate data from available IT systems in order to investigate safety issues
• Assists with the quality assurance of prepared responses regarding adverse experiences reported with company marketed products.
• Working knowledge of the label validation process, including MedDRA, and independent review of the product label for participation in this 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 programs to assist with data analysis.
• Manage programs and registries including the monitoring and follow-up of reports in special programs such as pregnancy registries, questionnaires and/or viral identification programs
• Participate in departmental and inter-departmental meetings and committees, as appropriate.
  Qualification, Skills & Experience:

Bachelor's degree in nursing, pharmacy or other relevant clinical health field and 4 years of relevant clinical health field experience. Pharmaceutical industry experience in the review and analysis of aggregate safety data and authoring of regulatory documents is preferred.

OR

Masters' degree in nursing, pharmacy or other relevant clinical health field 2 years of relevant clinical health field experience. Pharmaceutical industry experience in the review and analysis of aggregate safety data and authoring of regulatory documents is preferred.

This position requires demonstrated leaderships skills, excellent writing and verbal communication skills, problem solving ability, and analytical skills.

Proficiency with Microsoft program package (Word, Excel, and PowerPoint) is required with data management, quality assurance, and compliance experience highly desirable.

#Newco

Job Description In Secondary Posting Language(s) (include Requirements For Education, Experience And Skills)

Job Description In Secondary Posting Language(s) (include Requirements For Education, Experience And Skills)

US and Puerto Rico Residents Only:

If you need an accommodation for the application process please email us at staffingaadar@msd.com

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

EEOC GINA Supplement

OFCCP EEO Supplement

OFCCP Pay Transparency Rule

We are an equal opportunity employer, Minority/Female/Disability/Veteran - proudly embracing diversity in all of its manifestations.

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:
Remote Work

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings:
1

Requisition ID:R80766