Sr. Scientist, Drug Safety

Job Description

Under the direction of an Associate Principal Scientist/Principal Scientist, the Medical Associate will be responsible for support of activities within Clinical Safety and Risk Management for Devices and Product Quality and as a liaison to partners within company Research Laboratories Device Development, Manufacturing Division, Quality and Compliance, and the Risk Management Safety Team in support of the pipeline and marketed product portfolio throughout the product lifecycle.

Primary Responsibilities:

· Monitor, triage and assess requests received in the CSRM DPQ mailbox for Safety Assessments for Quality Investigations.

· Partners with CSRM DPQ Risk Assessment Physician in performing Safety Assessments for Quality Investigations, in the form of a Medical Assessment Memo (MAM) or a Health Hazard Evaluation (HHE) and contributes to implementation of updates to product risk management required as output of Health Risk Assessment.

· Authors Safety Assessments for Quality Investigations requested by Quality team or Quality and Compliance, to support a Quality investigation related to a Good Manufacturing Practice deviation, product complaint, regulatory non- conformance or other Quality-related issues involving drug, or stand-alone device products.

· Collaborates with the Safety Assessment requestor and the different functional areas involved in the Quality investigations, to ensure all relevant information to the issue under investigation is provided to permit an accurate and meaningful Safety Assessment.

· Reviews AE Quality Investigation Reports (AE QIRs) for applicable adverse event or lack of efficacy reports.

· Maintains DPQ owned templates.

· May support additional activities as part of Device Aggregate Safety Surveillance and Device Risk Management.

· Participates in the development, implementation and evaluation of standards, processes, metrics, and other department initiatives.

Requirements:

• ​Medical degree (MD).

• English proficiency at C1 level.

• Desirable experience in the pharmaceutical industry.

• Minimum of 2 years of clinical experience providing direct patient care as a physician.

• Desirable Master’s degree or specialization in Public Health or Epidemiology.

• Proficient in Microsoft Office Suite.

Required Skills:

Adaptability, Adaptability, Adverse Event Report, Clinical Experience, Clinical Risk Management, Clinical Safety, Data Analysis, Data Integrity, Decision Making, Device Development, Drug Safety Surveillance, Good Clinical Practice (GCP), Hazard Analysis, Liaison Communications, Medical Writing, Pharmacovigilance, Product Portfolio Management, Product Risk Management, Quality Assurance Review, Quality Management, Regulatory Compliance, Risk Management, Safety Audits, Safety Observations, Safety Reporting {+ 1 more}

Preferred Skills:

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Current Contingent Workers apply HERE

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Employee Status:

Regular

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Hybrid

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

06/8/2026

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