Senior Principal Scientist, Drug Safety

Merck; Frankfort (KY); A distancia; USD 282.000 - 444.000; Jornada completa

Descripción de la vacante

Merck is seeking a CSRM Physician to lead pharmacovigilance and risk management for assigned products. You will chair the Risk Management Safety Team, guide safety surveillance, and coordinate cross-functional efforts across clinical development, regulatory, epidemiology, and manufacturing.

The role emphasizes safety data evaluation, CTD components, risk management planning, and collaboration to ensure robust safety programs and regulatory compliance globally.

Formación

• MD/DO or equivalent required.
• Board certification preferred.
• Minimum 3 years clinical experience after training or relevant clinical experience.
• Experience in drug development and pharmacovigilance.

Responsabilidades

• Lead pharmacovigilance and risk management strategy for assigned products.
• Chairs of Risk Management Safety Team and oversees safety surveillance activities.
• Prepare safety summaries and regulatory documents; oversee labeling reviews.
• Collaborate with cross-functional teams to align safety strategies with global plans.

Conocimientos

Clinical Development

Clinical Risk Management

Clinical Safety

Clinical Training

Drug Development

Drug Safety Surveillance

Pharmacovigilance

Regulatory Documents

Risk Management

Safety Assessment Reports

Educación

MD/DO or equivalent

Board Certification (Preferred)

Herramientas

MedDRA

Descripción del empleo

Job Description

Position Overview

The CSRM Physician is a leader in pharmacovigilance and is responsible for the overall clinical risk management and safety surveillance of assigned investigational and marketed products. As chairs of the Risk Management Safety Team, CSRM physicians lead the development and maintenance of risk management and pharmacovigilance plans.

Primary Activities

• 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. This may include participation in internal and joint internal/external research project teams relevant to the development of new compounds and the further study of marketed compounds.
• Partners with clinical development to ensure that clinical programs will support robust safety assessment of investigational compounds. Works with Clinical Research to develop the benefit-risk evaluation in aggregate safety reports.
• The CSRM Physician works closely with cross-functional team members including those from clinical development, epidemiology, regulatory affairs, statistics, and manufacturing to manage safety topics under evaluation to ensure efforts are aligned to meet 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 and ensuring completeness of safety information in company core data sheets.
• Accountable for scientific strategy for safety related documents (e.g., CTD components, Risk Management Plans and Periodic Safety Update Reports) and for ensuring that the safety sections of Company product circulars are medically and scientifically appropriate.
• Responsible for safety surveillance activities for assigned products such as aggregate clinical trial data analysis and post approval safety signaling reviews, using medical judgment in review of aggregate data and individual cases. Collaborates with CSRM Associate in the oversight of safety surveillance activities for assigned products.
• Responsible for risk management activities such as contributing to recommendations for pharmacovigilance actions, making recommendations for labeling, and developing the Risk Management Plans, pharmacovigilance strategies and risk minimization activities in collaboration with CSRM Associate.
• Oversees the review and approval of product labeling files stored in the safety database and demonstrates a working knowledge of MedDRA.
• The CSRM Physician prepares safety summaries and analyses of safety related data for regulatory documents, aggregate reports, and summaries in support of regulatory filings and may supervise the activities of CSRM medical associates in the execution of safety data analysis and authoring of regulatory documents.
• Participates in the development, implementation and evaluation of standards, processes, metrics, and other department initiatives.

Education

• Required: MD, DO, or equivalent
• Preferred: Board Certification

Required Experience and Skills

• 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

Required Skills

Clinical Development, Clinical Risk Management, Clinical Safety, Clinical Training, Drug Development, Drug Safety Surveillance, Pharmacovigilance, Regulatory Documents, Risk Management, Safety Assessment Reports

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

EEOC Know Your Rights (https://www.eeoc.gov/sites/default/files/2022-10/22-088_EEOC_KnowYourRights_10_20.pdf)

EEOC GINA Supplement

We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.

Learn more about your rights, including under California, Colorado and other US State Acts (https://www.msdprivacy.com/us/en/CCPA-notice/)

The primary location for this posting is

USA - New Jersey - Rahway

Where required by law, the compensation range for this role is provided below.

The salary range for the primary location of this role is

$282,200.00 - $444,200.00

This range reflects the Company's reasonable expectation of the base salary applicable to this role at the time of posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits .

Additional location(s)

Please note the salary range above applies to the Primary Location of the position. Where a role has other listed locations, different compensation guidelines may apply. You may find the salary ranges for additional locations below. If the salary range is not listed for the location you are applying to, our Talent Acquisition team will provide further information to you relevant to your location.

Additional location(s) Compensation Information

San Francisco Residents Only

We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only

We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance

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

10%

Flexible Work Arrangements

Remote

Shift

Not Indicated

Valid Driving License

No

Hazardous Material(s)

n/a