Job Title: Senior Pharmacovigilance (PV) Physician I
Location: Employees can work remotely
Job Type: Full-time
Department: PV Medical Group
About the Company:
PrimeVigilance, part of Ergomed Group, is a specialized pharmacovigilance service provider established in 2008. The company has achieved consistent global organic growth, supporting pharmaceutical and biotechnology partners across Europe, North America, and Asia. PrimeVigilance offers services in Medical Information, Pharmacovigilance, Regulatory Affairs, and Quality Assurance, covering all therapy areas including medical devices. The company prioritizes investing in its staff, offering excellent training and development opportunities, and values work-life balance to ensure employee well-being and high-quality client service.
Job Responsibilities:
Medical Review & Causality Assessment:
Review and approve post-marketing ICSRs and SAE reports for medical/causality assessment
Review includes coding, seriousness assessment, listedness/expectedness, Company causality, and writing Company comments, follow-up questions, and Analysis of Similar Events when required
Completion of supporting documentation such as trackers
Qualified Person for Pharmacovigilance:
Act as a Qualified Person for Pharmacovigilance or support the QPPV in evaluating safety issues
Review and approve literature screening search strategies
Risk Management:
Review articles for ICSRs/SAEs related to the Medicinal Product or safety-related findings
Assist in preparing and providing input for Risk Management Plans
Regulatory Support & Signal Detection:
Lead preparation of responses to regulatory authority requests
Review and provide input on Periodic Safety Update Reports, Development Safety Update Reports, ACOs, and Annual Safety Reports
Act as the Company Lead in specific pharmacovigilance areas requiring medical input
Participate in signal detection activities, including meetings and reviewing signal detection reports
Provide consultation to clients regarding benefit/risk assessment and risk minimization
Training & Mentorship:
Provide training and mentoring to junior PV Physicians
Required Qualifications:
Education:
Medically qualified as a physician
Experience:
Previous experience in pharmacovigilance
Expertise in signal detection activities
Ability to review different aggregate reports, including PBRERs and DSURs
Skills:
Excellent interpersonal, communication, and presentation skills
Strong planning, organizing, and multitasking abilities
Ability to work cross-functionally and cross-culturally in a team environment
Advanced proficiency in English (spoken and written)
Advanced MS Office skills
Additional Information:
PrimeVigilance fosters a diverse, equitable, and inclusive workplace that welcomes people of all backgrounds, genders, and ages.
The company follows a human-first approach, recognizing that its people are the key to continued success and improving lives worldwide.
PrimeVigilance offers internal training, career development opportunities, and a supportive working environment with global colleagues.
Core values: Quality, Integrity & Trust, Drive & Passion, Agility & Responsiveness, Belonging, Collaborative Partnerships
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