Job Description

The Sr. Scientist Drug Safety will perform in line medical safety review of individual case safety reports (ICSRs) reports and other AE reports of interest:

1. As required per SOP and in conjunction with the ICMR Physician/Management and/or Therapeutic Area Team lead performs adverse experience reports review from specified sources in the safety database for regulatory reporting purposes

2. Apply knowledge of safety profiles for the adverse experience reports review

3. Develop working knowledge of pharmacovilance and regulatory reporting of ICSRs

4. Consult with the ICMR Physician/Management and/or Therapeutic Area Team lead for cases requiring additional clinical or safety subject matter expertise

5. May perform medical review of other reports of adverse events as required in conjunction with the ICMR Physician/Management and/or Therapeutic Area Team lead

6. May perform ICSR follow up activities in conjunction with the ICMR Physician/Management and/or Therapeutic Area Team lead

7. May participate in process, quality, innovation, technology and other business-related activities under the guidance of ICMR Physician/Management

8. May participate on special projects or rotational assignments within or outside of ICMR

The ICMR Associate with oversight from the ICMR Physician/Management and/or Therapeutic Area Team lead, may work closely and collaboratively with colleagues in other departments in the Company, including but not limited to: Global and US Pharmacovigilance, Global Pharmacovigilance Case Management, and Clinical Safety & Risk Management.

Education:

• Advanced/Graduate degree in nursing (e.g., MSN, CRNP), PharmD, Physician’s Assistant, M.D./D.O. or equivalent degree in Medicine, other relevant clinical health related field (undergraduate training is flexible) with an advance degree in a clinical discipline.

Required Experience and Skills:

• At least two years of clinical, pharmaceutical industry or related experience

• Clinically relevant medical experience

• The candidate must have strong understanding of scientific and medical concepts

• Excellent writing and communication skills in English

• Effective presentation skills and experience influencing and negotiating

• Computer skills - use of database and basic MS Office suite applications

• Problem solving, conflict resolution and critical thinking skills

Preferred Experience and Skills:

• Experience in drug safety, pharmacovigilance and/or risk management is highly desirable

• Prior medical review and/or case management experience

• Relevant Safety Systems Experience

• Drug development experience (early or late phase clinical research, regulatory affairs, and/or safety/PV)

Current Employees apply HERE

Current Contingent Workers apply HERE

Search Firm Representatives Please Read Carefully 
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. 

Employee Status:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Requisition ID:R338515