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Job Description

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Job Description:

The Lead Safety Data Specialist (LSDS) is responsible for processing and interpretation the most complex adverse events (AE) reports. The LSDS performs the execution of pharmacovigilance case management activities for investigational and/or marketed products, under the direction of a Global Pharmacovigilance Case Management (GPVCM) Manager. The LSDS completes AE related activities in compliance with our Company Standard Operating Procedures (SOPs) and guidelines. The LSDS collaborates with other staff within the organization as well as cross-functionally and is responsible for the quality and timely execution of processes.

What You’ll Do:

  • The LSDS performs all core responsibilities in processing of the most complex AE reports.
  • The LSDS performs the execution of pharmacovigilance case management activities for investigational and/or marketed products, under the direction of a GPVCM Manager.
  • The LSDS completes AE related activities in compliance with our Company Standard Operating Procedures (SOPs) and guidelines e.g. transitions failure monitoring.
  • The LSDS collaborates with other staff within the organization as well as cross-functionally and is responsible for the quality and timely execution of processes.
  • Independently and consistently meets Key Performance Indicators (KPIs) for quality and compliance.
  • Assists GPVCM Management to identify opportunities for business and/or operational process improvement to ensure/improve Quality and Compliance as well as increase efficiency and effectiveness. 
  • Assists GPVCM Management to prepare and respond to Regulatory Agency inspections as well as internal and external audits.
  • Monitors and analyzes key performance indicators to ensure adherence at process level and overall GPVCM team level. Assists with root cause analysis and oversees implementation of action plans when appropriate.
  • Serves as a GPVCM expert to effectively interact and communicate with internal and external stakeholders for the resolution of complex issues. Organizes and/or actively participates in the global network within GPVCM or with stakeholders to discuss process issues or inconsistencies, to create solutions, and works with Global Pharmacovigilance as appropriate to improve, standardize and optimize processes.
  • Provides process expertise and conducts periodic assessments (if needed) to ensure established processes are being followed consistently and appropriately.
  • Coordinates and performs quality and compliance assurance/control related processes and tasks.
  • Initiates and coordinates updates of guidance documents to guarantee global deliverables and alignment. Assists managers with the development and implementation of departmental procedures and educational programs.

You should apply if you have:

  • Bachelor’s Degree in Health Care or role related discipline
  • Advanced writing/reading and advanced speaking/listening English language skills.
  • Advanced writing/reading and Intermediate speaking/listening in one of the following: German, French, Italian, Spanish language skills.
  • Minimum 1,5 years’ experience in in Pharmacovigilance or role related field 

We encourage you to apply, especially if you have:

  • Master’s degree in Health Care

We set financial rates based on regular market reviews. We care about equality and comfort. We provide a high standard of work tools and great development opportunities.

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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:

Regular

Relocation:

No relocation

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Hybrid

Shift:

Valid Driving License:

Hazardous Material(s):

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Confirmed 12 hours ago. Posted 5 days ago.

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