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Pv Physician Ii

2+ 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

PV Physician II

Employees can work remotely
Full-time
Department: PV Medical Group

Company Description

We are PrimeVigilance, part of Ergomed PLC, a specialized mid-sized pharmacovigilance service provider established in 2008. We take pride in our global organic growth, with staff across Europe, North America, and Asia providing services in Medical Information, Pharmacovigilance, Regulatory Affairs, and Quality Assurance.

PrimeVigilance delivers top-notch support to pharmaceutical and biotechnology partners, maintaining long-lasting relationships and establishing ourselves as a global leader in the field. We cover all therapy areas, including medical devices.

We are committed to investing in our employees through excellent training and development programs. We value employee experience, well-being, and mental health, recognizing that a healthy work-life balance is crucial for satisfaction and high-quality client service.

Job Description

Responsibilities include:

  • Reviewing and approving post-marketing Individual Case Safety Reports (ICSRs) and Serious Adverse Event (SAE) reports for medical/causality assessment, including coding, assessment of seriousness, expectedness, and company causality.
  • Writing company comments, follow-up questions, and performing analyses of similar events when required, including completion of all necessary supporting documentation such as trackers.
  • Reviewing literature screening search strategies and articles to determine if they contain ICSRs/SAEs related to the relevant medicinal product or other safety-related findings.
  • Reviewing database outputs.
  • Contributing to Periodic Safety Update Reports and Development Safety Update Reports.
  • Participating in signal detection activities, including meetings and writing signal detection reports.
  • Proposing courses of action whenever a possible signal is identified.

Qualifications

  • Medically qualified as a physician with demonstrated experience in pharmacovigilance.
  • Experience in aggregate reports and signal detection is desirable.
  • Excellent interpersonal skills.
  • Strong planning, organizational, and multitasking abilities.
  • Ability to work effectively across cultures and functions, valuing teamwork.
  • Strong communication and presentation skills.

Additional Information

We prioritize diversity, equity, and inclusion by creating an equal-opportunity workplace that encourages contributions from all cultural backgrounds, genders, and ages.

Our success relies on a human-first approach, as our people are our greatest asset, leading to ongoing success 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 language.

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

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

Come and join us on this exciting journey to make a positive impact on patients' lives. We look forward to welcoming your application!