Job Description
The Vice President, Head of Clinical Safety and Risk Management is an experienced safety physician responsible for leading and overseeing the Clinical Safety and Risk Management (CSRM) department within Global Clinical Safety & Pharmacovigilance (GCS&PV).
The CSRM department represents patient safety on Product Development Teams (PDTs), leads the Risk Management and Safety Teams (RMSTs), and is accountable for proactively defining the safety profile, developing effective risk management plans, and ensuring transparent and accurate risk communication for all Company products.
The Head of CSRM is accountable to ensure that the team of Physicians, other HCPs and support staff lead the development of worldwide strategies for safety analysis for all products in the Company portfolio. The incumbent is accountable for supervising the assessment by CSRM of safety data from clinical trials and post approval pharmacovigilance, including all aspects of safety monitoring, risk management planning, safety strategy for regulatory submission dossiers and safety information in worldwide package circulars for our company's portfolio of products.
The Head of CSRM is responsible for leading and overseeing all CSRM efforts globally throughout the product life cycle. In particular, the VP provides leadership and oversight of: Therapeutically aligned teams supporting Oncology, Vaccines/Infectious Disease and General Medicine; Established Products Team; CSRM for Devices and Product Quality; CSRM Medical Safety Science and CSRM Business Processes and Systems.
The Head of CSRM reports directly to the Vice President, Global Clinical Safety & Pharmacovigilance (GCS&PV) and is Vice Chair of the Safety Review Committee (SRC), a routine attendee at Late Development Review Committee meetings, and a core member of the GCS & PV leadership team that partners across the organization to develop strategies for implementation of new regulations, such as the EU PV legislation. The role involves collaboration with IT colleagues to ensure appropriate database and system operations and enhancements to support departmental needs. Additionally, the Head of CSRM supports active business development via due diligence and subsequent acquisition support.
Primary Responsibilities:
Maintains medical safety oversight of issues and communications related to the safety profiles for all Company medicinal products – both marketed and investigational.
Ensures appropriate actions in response to emerging safety concerns.
Sits on relevant Governance, Management and Oversight Committees and Teams.
Vice Chair, Safety Review Committee (SRC)
Core Member of the GCS&PV Leadership Team
Agenda driven R&D Functional Head attendee of the Late Development Review Committee (LDRC)
Involvement in and has authority over the establishment and maintenance of aspects of the global PV system relevant to safety science, including quality control procedures and standard operating procedures in partnership with GCS&PV leadership.
Partners with the GCS&PV leadership and the R&D Compliance leadership to ensure and oversee robust pharmacovigilance quality management programs.
Represents our company externally, as appropriate, on regulatory/industry discussions on safety/PV issues and policies.
As organizational head and a people manager of 150 employees, the incumbent has direct influence on the department budget through oversight and approval of direct report expenses. Projects operational expenses and ensures compliance with departmental spending guidelines and headcount.
Education:
M.D. or equivalent
Required Experience and Skills:
MD plus 10 years of industry experience or experience in a related area; minimum of 5 years of experience in clinical safety/ PV (or equivalent); Prior experience as a manager of people
Minimum of 3 years prior clinical practice experience
Broad-based knowledge of the pharmaceutical development process, PV processes, and risk management.
Documented experience in pharmacovigilance with demonstrated knowledge of global requirements concerning pharmacovigilance and medical practices
Demonstrated ability to work effectively across functions and divisions and influence process and decisions at a senior management level
Required Skills:
Biostatistics, Clinical Judgment, Clinical Trial Planning, Communication, Detail-Oriented, Emotional Intelligence, Interpersonal Relationships, Marketing, Medical Writing, Mentoring Staff, Negotiation, People Leadership, Pharmacovigilance, Professional Networking, Regulatory Submissions, Risk Control Self AssessmentPreferred Skills:
Current Employees apply HERE
Current Contingent Workers apply HERE
US and Puerto Rico Residents Only:
Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.
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:
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
U.S. Hybrid Work Model
Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”.
The salary range for this role is
$378,100.00 - $595,100.00This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this 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.
You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.
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:
RegularRelocation:
VISA Sponsorship:
Travel Requirements:
Flexible Work Arrangements:
HybridShift:
Valid Driving License:
Hazardous Material(s):
Job Posting End Date:
04/18/2026*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.