Senior Pharmacovigilance Specialist – Belgium and Luxembourg

Senior Pharmacovigilance Specialist – Belgium and Luxembourg

Job title: Senior Pharmacovigilance Specialist – Belgium and Luxembourg

Company: MSD

Job description: Job Description

Do you have a degree in health, life science, medical science, regulatory affairs or equivalent by experience and at least two years of industry experience in pharmacovigilance? If you answered yes, we have a role for you!

For our Pharmacovigilance Department in Brussels we are currently recruiting a:

Senior Pharmacovigilance Specialist – Belgium and Luxembourg

The position

As a Senior Pharmacovigilance Specialist, you will be contributing to the day-to-day PV activities of the Pharmacovigilance Department in Brussels covering Belgium and Luxembourg. You will be responsible for PV activities (as delegated or assigned by your manager) which may include but are not limited to: PV intake, management and negotiation of local PV agreements, local due diligence activities, implementation and oversight of risk minimization measures, participation in audits and inspections and related readiness activities.

Activities would include, e.g.:

  • Developing local procedures (in compliance with regional and standards) for the department to ensure quality PV data and processes.
  • Being responsible for adverse event management including aggregate and individual case safety report health authority submissions and compliance monitoring.
  • Interfacing with colleagues from different functional areas, e.g. local Clinical Trial Operations, Regulatory Affairs department, to ensure alignment on issues impacting PV.
  • Supporting local initiatives (e.g. digital interfaces, marketing initiatives/ patient programs, organized data collection systems, etc.), and other programs to ensure compliance with PV requirements, as applicable. Serving as the point of contact for the local Health Authority for PV related questions from the Health Authorities (when assigned).
  • You will report into the Country PV Lead / PV Associate Director – Belgium and Luxembourg.

Position Qualifications:

  • Master’s/ Bachelor’s degree in health, life science, medical science, regulatory affairs or equivalent by experience.
  • At least two years of industry experience in pharmacovigilance or regulatory affairs in a pharmaceutical company/health authorities’ organization/ CRO/ consulting company providing pharmacovigilance services.
  • Knowledge of pharmacovigilance regulations in Belgium and Luxembourg and experience in interacting with PV auditors and preferably PV inspectors.
  • Ability to work in partnership with others (internally and externally) to accomplish quality goals.

Problem solving skills using creative thinking and data-collection from appropriate stakeholders to respond to new, complex, or problematic situations to influence organization direction.

Strong oral and written communication skills in English and French, Dutch is preferred.

Experience with MS-Office and preferably with other IT-applications.

We offer

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. We welcome you to a truly global, dynamic and challenging environment with great opportunities for personal development. We welcome you to a truly global, dynamic and challenging environment with great opportunities for personal development. Our benefits are very competitive and the summary below will give you an idea of what you can expect.

  • A competitive salary;
  • 32 vacation days;
  • Incentive Plan (bonus);
  • Health insurance plan;
  • An excellent pension;
  • Eco cheque;
  • Free use of gym;
  • Different training modules.

For questions about this vacancy

Please send an email including the vacancy number and job title to the following email address: [email protected]

Applications can only be submitted via our website.

Who we are …

We are known as Merck & Co., Inc., Kenilworth, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world’s most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.

What we look for …

In a world of rapid innovation, we seek brave Inventors who want to make an Impact in all aspects of our business, enabling breakthroughs that will affect generations to come. We encourage you to bring your disruptive thinking, collaborative spirit and diverse perspective to our organization. Together we will continue Inventing For Life, Impacting Lives while Inspiring Your Career Growth.

INVENT.

IMPACT.

INSPIRE.

Search Firm Representatives Please Read Carefully

Merck & Co., Inc., Kenilworth, NJ, USA, also known as Merck Sharp & Dohme Corp., Kenilworth, 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.

Current Employees apply

Current Contingent Workers apply

Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Kenilworth, NJ, USA, also known as Merck Sharp & Dohme Corp., Kenilworth, 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: No

Travel Requirements: 10%

Flexible Work Arrangements: Remote Work

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings: 1

Expected salary:

Location: Luxembourg

Job date: Sat, 22 May 2021 03:10:53 GMT

Apply for the job now!

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