Director, Drug Safety

Merck & Co., Inc.

Mobile Users click here

Merck is a global health care leader with a diversified portfolio of prescription medicines, vaccines and consumer health products, as well as animal health products. Today, we are building a new kind of healthcare company – one that is ready to help create a healthier future for all of us.

Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of people like you. To this end, we strive to create an environment of mutual respect, encouragement and teamwork. As part of our global team, you’ll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.

Responsible for the supervision and performance management of Clinical Safety and Risk Management Associates/Scientists skill sets in conducting their work of risk management and safety surveillance and the development of scientific publications and presentations. Assists the Executive Director with departmental oversight including budget, product assignments, and department development initiatives. Responsible for developing standard operating procedures for the work done by the Clinical Safety and Risk Management department, metrics to evaluate workload and performance, and process improvement initiatives to optimize work processes.

As a member of the CSRM management team, provides leadership to the department by participating in the setting of vision, objectives and goals for the department. Assumes leadership role in CSRM, modeling responsibility, accountability, competency, initiative, and ethical behavior.
Under the direction of the Executive Director, CSRM, and in conjunction with the CSRM physicians, responsible for ensuring the associate/scientists provide support in their repective roles for all departmental activities.
Responsible for the selection, training, supervision, development, and performance management of the CRMSS Associate/Scientist skill sets.
Develops SOPs for the CSRM department including safety review processes.
Utilizes process mapping and other process improvement tools to evaluate current work processes and procedures and takes the lead in implementing improvement initiatives resulting from the analysis. Develops, evaluates and maintains metrics, and utilizes metrics to optimize work processes.
Stays abreast of continuous changes in the regulation which may impact the work of the department and may require changes in work processes, procedures and SOPs.
Interacts with multiple stakeholders outside of CSRM, in particular functions on RMSTs.
Authors and supports CSRM staff to author manuscripts with CSRM and other Merck personnel for submission to peer reviewed journals. Gives oral and/or poster presentations at medical conferences.
Represents CSRM via active participation in interdepartmental meetings and committees. Consults and shares expertise within CSRM, and with multiple stakeholders outside of CSRM.
Through participation/presentions at meetings and other venues, educates MRL and other Merck departments about safety and risk management and the role of CSRM.

Education:

Required: Master's Degree in nursing, PharmD, PA or other relevant clinical health related field

Required Experience and Skills:

Clinically relevant medical experience in the undergraduate or graduate program is essential (e.g. nursing, pharm D, PA, or other relevant clinical health-related field).
Minimum of (10) years of professional experience with both clinical and pharmaceutical industry experience required, of which a minimum of (6) years MUST include safety experience (.e.g. PV or clinical); involving analysis of aggregate safety data and authoring of safety documents.
Excellent writing and communication skills a must. Experience in data analysis or the interpretation of adverse experience information is a plus.
Experience in data analysis or the interpretation of adverse experience information is a plus.
Demonstrated leadership skills in managing programs & processes, leading meetings and influencing peers to drive results.
Problem solving and critical thinking skills.

Preferred Experience and Skills:

People Management Experience.

Our employees are the key to our company’s success. We demonstrate our commitment to our employees by offering a competitive and valuable rewards program. Merck’s benefits are designed to support the wide range of goals, needs and lifestyles of our employees, and many of the people that matter the most in their lives. If you need an accommodation for the application process please email us at staffingaadar@merck.com.

Search Firm Representatives - Please read carefully:

Merck is not accepting unsolicited assistance from search firms for this employment opportunity. Please, no phone calls or emails. All resumes submitted by search firms to any employee at Merck via-email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of Merck. No fee will be paid in the event the candidate is hired by Merck as a result of the referral or through other means.

See full job details and apply at employer site