Senior Pharmacovigilance Physician & Risk Lead

Merck; Upper Gwynedd Township (Montgomery County); Remote; USD 282,000 - 444,000; Full time

Benefits offered by this job

Medical, Dental, Vision coverage

401(k) retirement plan

Paid holidays & vacation

Sick days

Job summary

Merck in Rahway, NJ seeks a CSRM Physician to lead pharmacovigilance and risk management for investigational and marketed products,chairing the Risk Management Safety Team and steering safety surveillance and pharmacovigilance plans.

The role collaborates with clinical development, epidemiology, regulatory affairs, statistics and manufacturing to ensure safety data is complete and accurately reflected in regulatory submissions and labeling.

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 directly 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, for assigned products.
• Partners with clinical development to ensure that clinical programs will support robust safety assessment of investigational compounds.
• Works with cross-functional team members including clinical development, epidemiology, regulatory affairs, statistics, and manufacturing to manage safety topics and align with global pharmacovigilance and risk management strategies.
• Duties include all aspects of safety data evaluation from multiple sources to ensure completeness of safety information in core data sheets.
• Accountable for scientific strategy for safety documents (CTD components, Risk Management Plans and PSURs) and for safe labeling content.
• Responsible for safety surveillance activities for assigned products such as aggregate data analysis and post-approval safety signaling reviews.
• Contributes to risk management activities, including labeling recommendations and development of risk minimization strategies with CSRM Associate.
• Oversees review and approval of product labeling files stored in the safety database and demonstrates knowledge of MedDRA.
• Prepares safety summaries and analyses for regulatory documents, aggregate reports, and summaries for regulatory filings.
• Participates in development, implementation and evaluation of standards, processes, metrics, and other department initiatives.

Education

MD/DO or equivalent

Board Certification

Job description

Merck in Rahway, NJ seeks a CSRM Physician to lead pharmacovigilance and risk management for investigational and marketed products,chairing the Risk Management Safety Team and steering safety surveillance and pharmacovigilance plans.

The role collaborates with clinical development, epidemiology, regulatory affairs, statistics and manufacturing to ensure safety data is complete and accurately reflected in regulatory submissions and labeling.