Clinical Safety and Risk Management Associate Principal Scientist

Job Description

As a Clinical Safety and Risk Management (CSRM) Associate Principal Scientist, you will play a critical role in protecting patient safety by actively monitoring, assessing, and communicating the safety profile of our medicines. You will perform medical and scientific review of adverse event data and work closely with Clinical Safety and Risk Management (CSRM) physicians and cross‑functional partners to identify and manage safety risks. Through your contributions to safety surveillance, risk management, and regulatory deliverables, you play a key role in ensuring patient safety.

What you will do

• Perform medical review of serious adverse event (SAE) reports and selected non‑serious adverse events to support ongoing safety surveillance

• Monitor and evaluate the overall safety profile of assigned products using individual case reports, aggregate safety data, scientific literature, and external databases

• Identify, investigate, and support assessment of safety signals in collaboration with CSRM physicians

• Select, analyze, and interpret safety data from validated safety and IT systems to support issue management and decision‑making

• Contribute to the development, maintenance, and monitoring of Risk Management Plans (RMPs) and, where applicable, Risk Evaluation and Mitigation Strategies (REMS)

• Prepare and support high‑quality responses to safety inquiries from health care professionals, regulatory authorities, affiliates, and internal stakeholders

• Author and contribute to safety sections of regulatory documents, including PSURs, DSURs, and summaries supporting regulatory submissions

• Act as a core member of the Risk Management Safety Team (RMST) and represent CSRM on cross‑functional teams and governance forums as appropriate

What skills you will need

To be successful in this role, you bring the following qualifications and skills:

• Medical Doctor (MD)

• Minimum 5 years of relevant professional experience combining clinical practice and pharmaceutical or biopharmaceutical industry experience

• At least 2 years must include drug safety, pharmacovigilance, or clinical safety experience (e.g., medical review, causality assessment, aggregate data analysis, safety document authoring)

• At least 2 years of post‑qualification clinical experience as a fully licensed physician, independently diagnosing and treating patients in a clinical care setting

• Solid working knowledge of pharmacovigilance and risk management principles

• Strong written and verbal communication skills in English

• Ability to critically analyze complex safety data and clearly communicate conclusions

• Experience working with safety databases and standard IT tools (e.g., MS Office)

• Proven experience authoring or contributing to regulatory safety documents (e.g., PSURs, DSURs, safety summaries)

• Proficiency in using safety databases and standard office applications (e.g., MS Office)

• Strong written and verbal communication skills in English, with the ability to prepare clear, structured safety‑related documentation

Preferred experience and skills

Ideally, you bring some of the following experience:

• Subject matter expertise in risk management processes, SOPs, and safety governance models

Candidates without prior pharmaceutical industry experience may be considered for a more junior entry‑level position, depending on overall background and demonstrated safety‑relevant experience.

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.

Required Skills:

Clinical Judgment, Drug Safety Surveillance, Medical Evaluation, Medical Review, Medical Surveillance, Patient Care, Periodic Safety Update Reports, Pharmacovigilance, Regulatory Compliance, Risk Management, Safety Assessment Reports

Preferred Skills:

Clinical Practice, Clinical Safety, Pharmaceutical Industry

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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. 

Employee Status:

Regular

Relocation:

No relocation

VISA Sponsorship:

No

Travel Requirements:

No Travel Required

Flexible Work Arrangements:

Hybrid

Shift:

Not Indicated

Valid Driving License:

No

Hazardous Material(s):

N/A

Job Posting End Date:

05/10/2026

*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.