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Benefit/Risk Officer

2+ years
Not Disclosed
10 Nov. 25, 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:
PrimeVigilance, part of the Ergomed Group, is a specialized pharmacovigilance service provider established in 2008. With global offices in Europe, North America, and Asia, we provide expert services in Medical Information, Pharmacovigilance, Regulatory Affairs, and Quality Assurance. Over the years, we have grown organically and built long-lasting relationships with pharmaceutical and biotechnology partners, becoming a leader in the industry. Our coverage spans all therapy areas, including medical devices.

We are committed to investing in our staff by offering excellent training, development opportunities, and a supportive work environment. We value employee well-being, mental health, and a healthy work-life balance to ensure satisfaction and high-quality client service. Join us on our journey to positively impact patient lives.

Job Description:
We are seeking a Benefit/Risk Officer with a life sciences or biomedical background, preferably a pharmacist, to join our team. This role will be involved in signal detection activities and the use of signal management tools, supporting pharmacovigilance activities for PrimeVigilance’s clients. You will work within project teams ranging from small clinical trials to large generic post-marketing projects. We are looking for proactive and motivated individuals who exceed expectations.

Key Responsibilities:

  • Participate in signal detection activities, including setup and review of line listings for signal detection reports.
  • Draft and perform quality control on complex signal detection reports.
  • Evaluate and categorize potential signals and propose actions when signals are identified.
  • Support communication with regulatory authorities and prepare related documentation.
  • Maintain relevant tracking tools and ensure accurate record-keeping.
  • Collaborate with other departments to ensure signal management aligns with PrimeVigilance procedures and regulatory requirements.

Qualifications:

  • Life sciences or biomedical background, preferably in pharmacy.
  • Experience in signal detection and using signal management tools is required.
  • Strong passion for learning and contributing to patient safety.
  • Excellent time management, organization, multitasking, and attention to detail.
  • Strong interpersonal and communication skills.
  • Advanced English language skills (B2 or higher, both verbal and written).

Additional Information:
At PrimeVigilance, we prioritize diversity, equity, and inclusion, creating a workplace where individuals from all backgrounds, genders, and ages can thrive. Our success is built on a human-first approach, where our people are our greatest strength.

What We Offer:

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

Core Values:

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

If you share these values, we would love to welcome your application to PrimeVigilance, where you can make a meaningful impact on patient safety.