Job Description

The Clinical Safety and Risk Management Physician is an expert in drug and/or vaccine safety and is responsible for the overall clinical risk management and safety surveillance of assigned marketed drugs/vaccines.  This includes all aspects of safety monitoring including assessing safety information and ensuring completeness of safety information in worldwide package circulars.  The Clinical Safety and Risk Management Physician is also responsible for the development of post-market risk management plans and pharmacovigilance strategies/specifications, and partners with appropriate departments to ensure efforts are aligned to meet our global risk management strategies for assigned products. 

The Clinical Safety and Risk Management Physician works closely with a cross-functional group of experts in epidemiology, regulatory affairs, statistics, and manufacturing to manage safety topics under evaluation to ensure efforts are aligned to meet our global pharmacovigilance and risk management strategies for assigned products. Duties include all aspects of safety data evaluation, including assessing safety from multiple sources, e.g. clinical trials, literature and post-approval use.Responsible for scientific strategy for safety related documents, and for ensuring that the safety sections of Company product circulars are medically and scientifically appropriate.Responsible for safety surveillance activities such as aggregate clinical trial data analysis and post approval safety signaling reviews, using medical judgment in review of summary data and individual cases as well as overseeing the medical judgment of other staff.Responsible for the development of risk management plans, pharmacovigilance strategies and risk minimizations activities as warranted.

Required

Minimum 2 years of clinical experience after completing educationMinimum 5 years of professional experience within the pharmaceutical industryAdvanced English proficiency (C2)At least 1 year in current role (internal candidates)Must have excellent written and verbal communication skills, as well as strategic and scientific thinkingDemonstrated leadership skills in meeting facilitation and problem solving Decision making and skills

Preferred experience and skills

3 years of safety experience (e.g. PV or clinical) involving causality assessment, analysis of aggregate safety data and authoring of safety documents.Training in public health, epidemiology, internal medicine, pediatrics

The Clinical Safety and Risk Management Physician is an expert in drug and/or vaccine safety and is responsible for the overall clinical risk management and safety surveillance of assigned marketed drugs/vaccines.  This includes all aspects of safety monitoring including assessing safety information and ensuring completeness of safety information in worldwide package circulars.  The Clinical Safety and Risk Management Physician is also responsible for the development of post-market risk management plans and pharmacovigilance strategies/specifications, and partners with appropriate departments to ensure efforts are aligned to meet our global risk management strategies for assigned products. 

The Clinical Safety and Risk Management Physician works closely with a cross-functional group of experts in epidemiology, regulatory affairs, statistics, and manufacturing to manage safety topics under evaluation to ensure efforts are aligned to meet our global pharmacovigilance and risk management strategies for assigned products. Duties include all aspects of safety data evaluation, including assessing safety from multiple sources, e.g. clinical trials, literature and post-approval use.Responsible for scientific strategy for safety related documents, and for ensuring that the safety sections of Company product circulars are medically and scientifically appropriate.Responsible for safety surveillance activities such as aggregate clinical trial data analysis and post approval safety signaling reviews, using medical judgment in review of summary data and individual cases as well as overseeing the medical judgment of other staff.Responsible for the development of risk management plans, pharmacovigilance strategies and risk minimizations activities as warranted.

Required

Minimum 2 years of clinical experience after completing educationMinimum 5 years of professional experience within the pharmaceutical industryAdvanced English proficiency (C2)At least 1 year in current role (internal candidates)Must have excellent written and verbal communication skills, as well as strategic and scientific thinkingDemonstrated leadership skills in meeting facilitation and problem solving Decision making and skills

Preferred experience and skills

3 years of safety experience (e.g. PV or clinical) involving causality assessment, analysis of aggregate safety data and authoring of safety documents.Training in public health, epidemiology, internal medicine, pediatrics

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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:

No relocation

VISA Sponsorship:

No

Travel Requirements:

No Travel Required

Flexible Work Arrangements:

Hybrid

Shift:

Not Indicated

Valid Driving License:

No

Hazardous Material(s):

no

Job Posting End Date:

01/15/2025

*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:R328846