Director, Clinical Safety & Risk Management (Vaccines/ID) Job

Gwynedd, PA, US
July 19 2017
Organization Type
Director, Clinical Safety & Risk Management (Vaccines/ID)-DRU000648


Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where Merck has codified its legacy for over a century. Merck’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.

Merck is on a quest for cures and is committed to being the world’s premier, most research-intensive biopharmaceutical company. Today, we’re doubling down on this goal. Merck Research Laboratories is a true scientific research facility of tomorrow, and will take Merck’s leading discovery capabilities and world-class small molecule and biologics R&D expertise to create breakthrough science that radically changes the way we approach serious diseases.

Merck is well known for
its many contributions to the prevention and control of infectious diseases, and
continues as a global leader in vaccines, as well as antiviral, antibacterial,
and anti-fungal therapeutic agents. Under the general direction of an Executive Director in Clinical Safety and Risk Management, the CSRM Senior Principal Scientist is a leader in Drug and/or Vaccine Safety and is responsible for the overall Clinical Risk Management and Safety Surveillance of assigned investigational and marketed drugs/vaccines.

Key responsibilities
include and are not limited to the following:

- Support product development activities via Risk
Management and Safety Teams and Product Development Teams and other
related sub-team participation, including participation in internal and
joint internal/external research project teams relevant to the development
of new compounds, and the further study of marketed compounds.

- The CSRM Senior Principal Scientist may work closely
with a cross-functional group of experts in Epidemiology, Regulatory
Affairs, Statistics, and Manufacturing to manage safety topics under

- Duties include all aspects of Safety Data Evaluation,
including assessing safety from a variety of sources, e.g. clinical
trials, literature and post-approval use and ensuring completeness of
safety information in worldwide package circulars.

- Responsible for Safety Surveillance activities such as
signaling reviews using medical judgment in review of individual cases as
well as overseeing the medical judgment of other staff.

- Risk Management activities such as contributing to
recommendations for PV actions and making recommendations for labeling.

- Ensuring that the safety section of product circulars
are medically and scientifically appropriate.

- Analyzing and summarizing the findings from available
safety data to support decisions.

- The CSRM Senior Principal Scientist may supervise the
activities of CSRM Staff in the execution of safety data analysis and
medical writing.

- Responsible for the development of worldwide
post-market risk management plans, pharmacovigilance strategies and risk
minimizations activities as warranted

- Contribute to medical presentations and scientific

- Interactions with public health authorities to support
the safe and proper use of products



- MD, DO, or equivalent


- Minimum of (3) years Clinical experience after completing education
- Minimum of (2) years industry experience in Clinical Research / Clinical Development and / or Drug Safety / Pharmacovigilance / Risk Management
- Must have excellent written and verbal communication skills as well as analytical skills


- Industry experience in both an Investigational and
Post-Market capacity

- Board certification highly desirable

- Training and/or experience in public health,
epidemiology, and/or quantitative sciences

Your role at Merck is integral to helping the world meet new breakthroughs that affect generations to come, and we’re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At Merck, we’re inventing for life.

If you need an accommodation for the application process please email us at

Search Firm Representatives Please Read Carefully:

Merck & Co., Inc. 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.

For more information about personal rights under Equal Employment Opportunity, visit:

EEOC Poster

EEOC GINA Supplement​

Merck is an equal opportunity employer, Minority/Female/Disability/Veteran – proudly embracing diversity in all of its manifestations.

Job: Drug Safety Surveillance (MD)

Job Title:Sr. Principal Scientist, Drug Safety

Primary Location: NA-US-PA-Upper Gwynedd

Other Locations: NA-US-NJ-Rahway

Employee Status: Regular

Travel: Yes, 10 % of the Time

Number of Openings: 3

Company Trade Name:Merck

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