Vice President, Clinical Safety & Risk Management

MSD•North Wales, PA

20h•Hybrid

About The Position

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.

Requirements

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
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 Assessment

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.