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Director, Clinical Safety and Risk Management. Job in Upper Gwynedd, Pennsylvania, United States in Merck & Co., Inc.. Nelest.com
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Director, Clinical Safety and Risk Management

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Job ID:

22165

Location:

Upper Gwynedd, PA 

Job function:

Medical Services, Public Relations
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Posted:

03.05.2016

Employment Type:

Full time

Industry:

Healthcare / Pharma
col-wide   

Title:

Director, Clinical Safety and Risk Management

Job Description:

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 the Clinical Risk Management Group Lead, the CRM Physician is an expert 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. This includes all aspects of safety monitoring including assessing safety information and ensuring completeness of safety information in worldwide package circulars. The incumbent is also responsible for the development of post-market risk management plans and pharmacovigilance strategies/specifications.

The incumbent is a member of the Product Development Teams and chairs the Risk Management and Safety subteam for assigned products. Partners with appropriate Merck departments and therapeutic area heads to ensure efforts are aligned to meet our gloal risk management strategies for assigned products. Works with CRM Group Lead to plan direction for risk management functions of the department, helps develop processes for the function of the program, and implement specific programs to achieve identified goals. Travel: Yes, 5 % of the Time Description Director, Clinical Safety and Risk Management-DRU000437 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 the Clinical Risk Management Group Lead, the CRM Physician is an expert 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. This includes all aspects of safety monitoring including assessing safety information and ensuring completeness of safety information in worldwide package circulars. The incumbent is also responsible for the development of post-market risk management plans and pharmacovigilance strategies/specifications.
The incumbent is a member of the Product Development Teams and chairs the Risk Management and Safety subteam for assigned products. Partners with appropriate Merck departments and therapeutic area heads to ensure efforts are aligned to meet our gloal risk management strategies for assigned products. Works with CRM Group Lead to plan direction for risk management functions of the department, helps develop processes for the function of the program, and implement specific programs to achieve identified goals. Qualifications Education:
  • MD/DO or equivalent

Job Requirements:

Qualifications Education:
  • MD/DO or equivalent
Required:
  • Minimum three (3) years Clinical Experience
  • Experience in drug safety, pharmacovigilance and/or risk management
  • Industry experience desirable in both an investigational and post-marketed capacity
  • Must have excellent communication, writing and analytic skills
Preferred:
  • Safety coding
  • Safety listedness assessment
  • Individual case review
  • Aggregate safety
  • Analysis experience
  • Signal identification and evaluation
  • Experience with regulatory interactions including regulatory responses
  • Periodic reports
  • Leadership skill, team work approach, Good interpersonal skill.
  • Board Certification is 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. Visa sponsorship is not available for this position. 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.

Zip Code:

19446

Company Info
Merck & Co., Inc.

Kenilworth, NJ, United States

Phone:
Web Site: merck.com

Company Profile

Company Info


Merck & Co., Inc.
Kenilworth, NJ, United States
Phone:
Web Site: merck.com

Director, Clinical Safety and Risk Management

col-narrow-left   

Job ID:

22165

Location:

Upper Gwynedd, PA 

Job function:

Medical Services, Public Relations
col-narrow-right   

Posted:

03.05.2016

Employment Type:

Full time

Industry:

Healthcare / Pharma
col-wide   

Title:

Director, Clinical Safety and Risk Management

Job Description:

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 the Clinical Risk Management Group Lead, the CRM Physician is an expert 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. This includes all aspects of safety monitoring including assessing safety information and ensuring completeness of safety information in worldwide package circulars. The incumbent is also responsible for the development of post-market risk management plans and pharmacovigilance strategies/specifications.

The incumbent is a member of the Product Development Teams and chairs the Risk Management and Safety subteam for assigned products. Partners with appropriate Merck departments and therapeutic area heads to ensure efforts are aligned to meet our gloal risk management strategies for assigned products. Works with CRM Group Lead to plan direction for risk management functions of the department, helps develop processes for the function of the program, and implement specific programs to achieve identified goals. Travel: Yes, 5 % of the Time Description Director, Clinical Safety and Risk Management-DRU000437 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 the Clinical Risk Management Group Lead, the CRM Physician is an expert 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. This includes all aspects of safety monitoring including assessing safety information and ensuring completeness of safety information in worldwide package circulars. The incumbent is also responsible for the development of post-market risk management plans and pharmacovigilance strategies/specifications.
The incumbent is a member of the Product Development Teams and chairs the Risk Management and Safety subteam for assigned products. Partners with appropriate Merck departments and therapeutic area heads to ensure efforts are aligned to meet our gloal risk management strategies for assigned products. Works with CRM Group Lead to plan direction for risk management functions of the department, helps develop processes for the function of the program, and implement specific programs to achieve identified goals. Qualifications Education:
  • MD/DO or equivalent

Job Requirements:

Qualifications Education:
  • MD/DO or equivalent
Required:
  • Minimum three (3) years Clinical Experience
  • Experience in drug safety, pharmacovigilance and/or risk management
  • Industry experience desirable in both an investigational and post-marketed capacity
  • Must have excellent communication, writing and analytic skills
Preferred:
  • Safety coding
  • Safety listedness assessment
  • Individual case review
  • Aggregate safety
  • Analysis experience
  • Signal identification and evaluation
  • Experience with regulatory interactions including regulatory responses
  • Periodic reports
  • Leadership skill, team work approach, Good interpersonal skill.
  • Board Certification is 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. Visa sponsorship is not available for this position. 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.

Zip Code:

19446
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