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Director, Clinical Safety & Risk Management Job

Employer
Merck
Location
Upper Gwynedd PA
Closing date
Oct 11, 2016

Job Details

Director, Clinical Safety & Risk Management-DRU000516

Description

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. 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 an individual 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.


Under the general direction of an Executive Director in Clinical Safety and Risk Management, the CSRM 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 Principal Scientist may work closely with a cross-functional group of experts in Epidemiology, Regulatory Affairs, Statistics, and Manufacturing to manage safety topics under evaluation.
- 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 our product circulars are medically and scientifically appropriate.
- Analyzing and summarizing the findings from available safety data to support decisions.
- The CSRM 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.

Qualifications

Education:

- Required: MD, DO, or equivalent

Required:

- Minimum of (3) years Clinical experience after completing education
- Must have excellent written and verbal communication skills as well as analytical skills
- 5 – 10% Travel

Preferred:

- Experience in Drug Safety, Pharmacovigilance and/or Risk Management
- Industry experience in both an Investigational and Post-Market capacity
- Board certification highly desirable
- Subspecialty in Epidemiology, or other related subspecialty preferred

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. Our Company’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 & 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: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: 1

Shift (if applicable): 1st

Company Trade Name:Merck

Company

Our vision is to make a difference in the lives of people globally through our innovative medicines, vaccines, biologic therapies, consumer health and animal products. We aspire to be the best healthcare company in the world and are dedicated to providing leading innovations and solutions for tomorrow.

We have made it our mission to provide innovative, distinctive products and services that save and improve lives, satisfy customer needs and to be recognized as a great place to work

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