Clinical Safety and Risk Management Associate Principal Scientist

Job Description

The Clinical Safety and Risk Management Medical Associate Principal Scientist performs primary medical review of serious adverse experience (AE) reports and other AE reports of interest in order 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 (RMPs) of assigned products under the direction/guidance of the CSRM physician.

Assists the CSRM physician to prepare responses to inquiries from health professionals and regulatory agencies regarding adverse experiences reported for assigned products.

In collaboration with the CSRM physician, strategizes with the Risk Management Safety Team (RMST) recommending appropriate data to respond to queries and analyze data.

Primary activities include, but are not limited to:

• Applies clinical, pharmacological, and epidemiologic knowledge and information technology (IT) skills in order to manage the safety surveillance and risk management of assigned products in collaboration with the CSRM physician
• In collaboration with the CSRM physician, accountable for monitoring the overall safety profile of assigned products and for describing the safety profile to ensure external communications regarding the safety of these products are accurate
• Performs safety surveillance review of adverse experience reports for assigned products which includes reviewing individual AE reports, aggregate safety data, published literature, and information from external databases
• Works with CSRM physician to select and analyze the appropriate data from available IT systems in order to investigate safety issues
• Prepares responses to safety inquiries from health care professionals, regulatory agencies, subsidiary staff, and other internal customers
• Demonstrates a working knowledge of pharmacovigilance and risk management; may educate stakeholders outside of CSRM about risk management and the role of CSRM
• Prepares summaries and analyses of safety related data for regulatory documents such as Periodic Safety Update Reports (PSURs), Developmental Safety Update Reports (DSURs) and summaries in support of regulatory filings
• Core member of RMST; represents CSRM on cross-functional teams and committees as appropriate. Assists the RMST with the development, maintenance, and monitoring of RMPs and Risk Evaluation and Mitigation Strategies (REMS) for assigned products
• Participates in the development, implementation and evaluation of standards, processes, metrics, and other department initiatives.

Qualifications, Skills and Experience:

• At least two years of clinical experience in a patient care setting is required
• Minimum 5 years of professional experience with both clinical and pharmaceutical industry experience required, of which a minimum of 2 years MUST include safety experience (e.g. PV or clinical) involving causality assessment, analysis of aggregate safety data and/or authoring of safety documents.
• Experience in drug safety, pharmacovigilance and/or risk management
• Excellent writing and communication skills in English
• Demonstrated leadership skills in managing programs, processes, and facilitating meetings
• Effective presentation skills and experience influencing and negotiating
• Computer skills - use of database and basic MS Office suite applications
• Problem solving, conflict resolution and critical thinking skills

Preferred Experience and Skills:

• Subject matter expertise in specific departmental programs, SOPS, and departmental initiatives.

Education:

• Medical Doctor (MD)

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Search Firm Representatives Please Read Carefully

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.

Employee Status:

Regular

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Hybrid

Shift:

Valid Driving License:

Hazardous Material(s):

Required Skills:

Adaptability, Adaptability, Audit Process Evaluations, Clinical Judgment, Communication, Compliance Program Development, Critical Thinking, Data Analysis, Decision Making, Detail-Oriented, Drug Safety Surveillance, Ethical Compliance, Internal Customers, Medical Review, Medical Writing, Periodic Safety Update Reports, Pharmacovigilance, Post Marketing Surveillance, Product Risk Management, Product Safety, Regulatory Communications, Regulatory Compliance, Regulatory Compliance Audits, Risk Management, Safety Management {+ 3 more}

Preferred Skills:

Job Posting End Date:

10/1/2025

• A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Requisition ID:R361439