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Benefit/Risk Officer I

5-10 years
Not Disclosed
10 Oct. 17, 2024
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Company Description

We are PrimeVigilance, part of the Ergomed Group, a specialized mid-sized pharmacovigilance service provider established in 2008. We are proud to have achieved consistent global organic growth, with staff located across Europe, North America, and Asia, providing services in Medical Information, Pharmacovigilance, Regulatory Affairs, and Quality Assurance.

PrimeVigilance offers top-tier support to our pharmaceutical and biotechnology partners, fostering long-lasting relationships and establishing ourselves as a global leader in the industry. We cover all therapy areas, including medical devices.

We are committed to investing in our staff through excellent training and development opportunities. We prioritize employee experience, well-being, and mental health, recognizing that a healthy work-life balance is essential for job satisfaction and quality client service.

Join us on this exciting journey to make a positive impact on patients' lives!

Job Description

The Benefit/Risk Officer should have a life science or biomedical background, preferably in pharmacy, with experience in signal detection and the use of signal management tools. This role involves working as part of a project team to perform and support contracted pharmacovigilance activities on behalf of PrimeVigilance.

If you join PrimeVigilance, you can expect to work with teams of varying sizes, from small clinical trials to large generic post-marketing teams. We are always looking for proactive, capable, and motivated individuals who aim to exceed any targets set before them.

Responsibilities:

  • Participate in signal detection activities, including setup.
  • Review line listings for signal detection report preparation.
  • Draft complex signal detection reports, including quality control.
  • Evaluate and categorize potential signals.
  • Propose actions when a potential signal is identified.
  • Assist in preparing communications with regulatory authorities.
  • Maintain record-keeping and tracking tools.
  • Collaborate with other departments to ensure signal management aligns with PrimeVigilance procedures and regulatory requirements.

Qualifications

  • Life science or biomedical background, preferably pharmacy.
  • 5-10 years of experience in signal detection and the use of signal management tools.
  • A passion for learning and contributing to patient safety.
  • Strong skills in time and issue management, delegation, organization, and multitasking, with attention to detail.
  • Excellent interpersonal and communication skills.
  • Advanced English proficiency (at least B2) in both verbal and written forms.

Additional Information

Why PrimeVigilance?

We prioritize diversity, equity, and inclusion, fostering an equal opportunity workplace where individuals from all backgrounds can contribute and grow. Our human-first approach is crucial to our success, as our people are our greatest strength in improving lives.

We offer:

  • Internal training and career development opportunities.
  • Strong emphasis on personal and professional growth.
  • A friendly and supportive working environment.
  • Opportunities to collaborate with colleagues worldwide, with English as the primary company language.

Our core values guide our operations, and if they resonate with you, PrimeVigilance could be the perfect place for you!

  • Quality
  • Integrity & Trust
  • Drive & Passion
  • Agility & Responsiveness
  • Belonging
  • Collaborative Partnerships

We look forward to welcoming your application!