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PV Specialist- Clinical Safety

Remote: 
Full Remote
Contract: 
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Offer summary

Qualifications:

Bachelor’s degree in medical, natural sciences, or pharmacy-related field, or Degree in Medicine., At least 1 year of relevant professional experience in Pharmacovigilance., Knowledge of safety databases such as Argus or Safety Easy is preferred., Fluent written and spoken English skills with excellent communication abilities..

Key responsabilities:

  • Management of SAEs/AESIs/pregnancies and ensuring all parties are informed as required.
  • Initial triage of SAEs and data entry in the safety database.
  • Support Safety Manager with case reviews and preparation of line listings.
  • Maintenance of trackers and administrative activities related to safety submissions.

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Lash Group Pharmaceuticals Large https://www.lashgroup.com/
1001 - 5000 Employees
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Job description

Our team members are at the heart of everything we do. At Cencora, we are united in our responsibility to create healthier futures, and every person here is essential to us being able to deliver on that purpose. If you want to make a difference at the center of health, come join our innovative company and help us improve the lives of people and animals everywhere. Apply today!

Job Details

PV specialist – Clinical Safety

We have an exciting opportunity for a PV Specialist to join our Clinical Safety team! This role can be based remotely in Spain and we are, above all else, looking for an individual who is motivated and enthusiastic to grow with our Pharmalex brand which has seen great success.

  • Management of SAEs/AESIs/pregnancies
  • Assure all parties are informed as required & querying the sites when needed; follow the whole process for each case/remind parties of pending information when applicable.
  • Initial triage (assessment of expectedness/seriousness) of SAEs.
  • Data Entry in safety database
  • Narrative writing
  • Support Safety Manager with Review of cases in safety database (QC)
  • Preparation of Line Listings
  • Maintaining annual plans for LLs / DSURs and distribution lists.
  • Safety submissions.
  • Maintenance of trackers and other administrative activities.

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Skills

  • Team-oriented approach
  • Organizational skills, ability to multi-task. Ability to assimilate and analyse information rapidly.
  • High sense of responsibility and self-motivation
  • Highly service-oriented
  • Flexibility and adaptability to adjust rapidly to new, unknown, challenging situations.
  • Fluent written and spoken English skills.
  • Excellent written and verbal communication skills.

Experience/Background

  • Successful completion of a Bachelor’s degree in medical, natural sciences or pharmacy-related field or Degree in Medicine
  • At least 1 year of relevant professional experience in the field of Pharmacovigilance.
  • Knowledge of safety databases (Argus, Safety Easy are preferred)
  • Experience in case management activities
  • Previous experience in pre-authorisation area.

What Cencora offers

​Benefit offerings outside the US may vary by country and will be aligned to local market practice. The eligibility and effective date may differ for some benefits and for team members covered under collective bargaining agreements.

Full time

Affiliated Companies
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Equal Employment Opportunity

Cencora is committed to providing equal employment opportunity without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, age, disability, veteran status or membership in any other class protected by federal, state or local law.

The company’s continued success depends on the full and effective utilization of qualified individuals. Therefore, harassment is prohibited and all matters related to recruiting, training, compensation, benefits, promotions and transfers comply with equal opportunity principles and are non-discriminatory.

Cencora is committed to providing reasonable accommodations to individuals with disabilities during the employment process which are consistent with legal requirements. If you wish to request an accommodation while seeking employment, please call 888.692.2272 or email hrsc@cencora.com. We will make accommodation determinations on a request-by-request basis. Messages and emails regarding anything other than accommodations requests will not be returned

Required profile

Experience

Industry :
Pharmaceuticals
Spoken language(s):
English
Check out the description to know which languages are mandatory.

Other Skills

  • Adaptability
  • Communication
  • Teamwork
  • Physical Flexibility
  • Self-Motivation

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