Associate Principal Scientist, Drug Safety, Women’s Health Job at MSD in Gwynedd, PA
We are seeking candidates with an entrepreneurial and learning spirit who are interested in a career of purpose, personal growth and leadership.
Supports the CSRM team in the safety surveillance of assigned products. Proficient in retrieval, and preliminary analysis of safety data 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 a leadership role in the oversight and development of pharmacovigilance and risk management plans 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.
Position Can be Based Remotely
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)
- Leads CSRM team to prepares data for retrieval and analysis which may include querying the safety surveillance databases, preparing spreadsheets for interpretation and review of data output.
- 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.
- Collaborates with CSRM team to select and analyze the appropriate data from available IT systems in order to investigate safety issues
- Independently responds to requests posed by internal customer
- Lead the quality assurance of prepared responses to inquiries from health professionals, regulatory agencies and other customers regarding adverse experiences reported with company marketed products
- Advanced knowledge of the label validation file process, including MedDRA, and independent review of the product label for participation in this process. Collaborates with the CSRM team 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.
- Advanced knowledge of 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. Manage outside contracts for such programs and/or consultants. Attend periodic program meetings, reporting issues to CSRM physician/management
Serve as a functional area representative to groups outside of CSRM. Qualification, Skills & Experience
Bachelor’s degree in nursing, pharmacy or other relevant health field is required. A minimum of 4 years of relevant clinical health field experience and 4 years of relevant Pharmacovigilance experience in the review of aggregate safety data and authoring of safety documents is required.
Masters degree in nursing, pharmacy or relevant health field is required A minimum of 2 years of relevant clinical health field experience and 4 years relevant Pharmacovigilance experience in the review of aggregate safety data and authoring of safety documents is required. .
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.
US and Puerto Rico Residents Only:
If you need an accommodation for the application process please email us at
For more information about personal rights under Equal Employment Opportunity, visit:
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
Flexible Work Arrangements:
Valid Driving License:
Number of Openings: 1
Company Location: Gwynedd, PA