직업 종류: Full-time

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작업 내용

Job Description

For our team in Lucerne we are currently looking for a Pharmacovigilance Specialist (m/f/d).

You will be responsible for PV activities which may include but is not limited to PV Intake activities (including reconciliation and followup), Individual case safety report (ICSR) and aggregate submissions, compliance monitoring, management and negotiation of local PV agreements, local due diligence activities, supporting audits and inspections and related readiness activities, authoring local SOPs, conducting local training, and archiving and is able to perform these tasks with minimal supervision.

Our Regulatory Affairs team bring new medical advancements to the world by facilitating communications and procedures that allow swift, organized compliance partnering with external regulatory agencies. We are on the leading-edge of healthcare breakthroughs that help provide new, reliable, and compliant medical products, practices and solutions to the world.

Specific details of tasks and responsibilities of the local QPPV, Local PV Contact / Local

Responsible PV Person and Country PV staff may be further described in an addendum

to this job description. Activities listed below are applicable for all supported countries
  • Responsible for execution of local PV processes and activities in collaboration with internal functional areas and external parties as assigned
  • Responsible for day-to-day adverse events case management including case intake, tracking, translation to English (as applicable), acknowledgments, and follow-up activities in accordance with PV procedures and country regulations
  • Responsible for reporting adverse experiences or events (AE) or product quality complaints (PQCs) associated with the use of our company products in compliance with our policies
  • Support local PV audits and inspections including readiness activities and supports audits of business partners/vendors including the development of CAPAs in response to findings/observations as assigned
  • Participate in compliance activities and coordinates the preparation of necessary corrective actions locally for late reports
  • Assists in developing and maintaining local procedures (in compliance with regional and global standards), to ensure global quality PV data and evaluates processes for potential improvement in efficiency and effectiveness
Qualifications & Experience
  • You hold a Health, Life Science, or Medical Science degree or equivalent by education/experience
  • You have first experience on safety and pharmacovigilance related activities
  • You possess a general knowledge of AE reporting requirements and relevant PV regulations
  • You are fluent in English and German, French and/or Italian language skills are of advantage
  • You are a strong communicator and organizational talent
  • You are able to work in partnership with others (internally and externally) to accomplish quality goals
  • You are able to interface broadly with colleagues within related functions and cross-functionally and be able to work independently with no supervision except in the most complex of situations
  • You demonstrate skills to drive change that enhances processes within the company or crossfunctionally that improve quality and /or add value to the business.
We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” that great medicines can make a significant impact to our world. We believe that a research-driven enterprise dedicated to world-clasenting medicine and vaccine innovations that make a difference for patients across the globe.

The Company

Our company has had a presence in Switzerland since 1963. With a regional office and manufacturing/packaging facility, Lucerne is considered the center of operations. Approximately 1,000 people work collaboratively at the four Lucerne locations (Tribschenstrasse, Citybay, Schachen and Kriens). A fifth location has been recently established in Zurich, aimed at accelerating the development and commercialization of many of our company’s medicines and vaccines, which supports our mission to save and improve lives around the world. The new location has a target date of 2021 for operational readiness.

We are proud to be certified as a “Top Employer Switzerland” and “Top Employer Europe” showing the company’s commitment to our employees and the community around us.

The Switzerland Head Office of our company’s Swiss Subsidiary is based in Lucerne’s city centre. Located in the heart of the city, employees work collaboratively across many departments including commercial, market access, medical affairs, clinical research, regulatory affairs, and policy & communications.

Who We Are …

We are known as Merck & Co., Inc., Rahway, 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 …

Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us—and start making your impact today.

We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.

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

Regular

Relocation

No relocation

VISA Sponsorship

No

Travel Requirements

No Travel Required

Flexible Work Arrangements

Work Week

Shift

Valid Driving License

Hazardous Material(s)

Number of Openings

1

Requisition IDR178978
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마감 시간: 04-05-2024

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