Senior Principal Scientist, Pharmacovigilance & Risk Lead

Merck; Atlanta (GA); Remote; USD 282,000 - 444,000; Full time

Job summary

Merck is seeking a CSRM Physician to lead pharmacovigilance and risk management for assigned products. You will chair the Risk Management Safety Team and drive safety surveillance, safety data interpretation, and regulatory support across product life cycles.

The role requires MD/DO or equivalent with 3+ years of clinical experience and experience in drug development, pharmacovigilance, and risk management.

Qualifications

• Minimum of 3 years clinical experience following post-graduate medical training or other relevant clinical experience.
• Prior experience in drug development (may include clinical development and/or regulatory)
• Experience in clinical safety, pharmacovigilance and/or risk management
• Demonstrated organizational leadership skills, preferably in the employment areas noted above.
• Excellent communication, writing and analytic skills

Responsibilities

• Engage in product development activities via core membership on Product Development Teams and chairmanship of the Risk Management and Safety Team, and other related sub-team participation.
• Partner with clinical development to ensure robust safety assessment of investigational compounds and develop benefit-risk evaluation in aggregate safety reports.
• Collaborate with cross-functional team members to manage safety topics and align with global pharmacovigilance strategies.
• Perform safety data evaluation from multiple sources (clinical trials, literature, post-approval) and ensure complete safety information.
• Develop safety documents (CTD components, Risk Management Plans, PSURs) and ensure appropriate medical/theoretical content.
• Oversee safety surveillance activities and provide guidance for labeling and risk management strategies.

Skills

Clinical Development

Clinical Risk Management

Clinical Safety

Clinical Training

Drug Development

Drug Safety Surveillance

Pharmacovigilance

Regulatory Documents

Risk Management

Safety Assessment Reports

Education

MD, DO, or equivalent

Board Certification

Job description

Merck is seeking a CSRM Physician to lead pharmacovigilance and risk management for assigned products. You will chair the Risk Management Safety Team and drive safety surveillance, safety data interpretation, and regulatory support across product life cycles.

The role requires MD/DO or equivalent with 3+ years of clinical experience and experience in drug development, pharmacovigilance, and risk management.