Pharmacovigilance Physician

Theramex

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profile Job Location:

Warszawa - Poland

profile Monthly Salary: Not Disclosed
Posted on: Yesterday
Vacancies: 1 Vacancy

Job Summary

The Pharmacovigilance Physician will provide medical and clinical expertise strategic oversight and handson support to ensure robust safety surveillance and riskmanagement compliance across all Theramex products. Acting as the global medical safety expert this role leads safety governance drives signal detection and risk mitigation contributes to scientific analyses and ensures highquality safety documentation for internal and regulatory audiences.

About You

You will bring:

  • Medical Doctor (MD) qualification; prior experience as EU QPPV or Deputy QPPV advantageous.

  • Previous experience in Drug Safety / Pharmacovigilance with strong understanding of global PV regulations.

  • Demonstrated expertise in authoring and reviewing aggregate safety reports (RMPs PSURs).

  • Excellent medical writing skills and strong analytical ability.

  • Experience contributing to interventional and noninterventional studies.

  • Proven ability to manage multiple strategic and operational projects simultaneously.

  • Strong influencing skills with the ability to engage stakeholders at all levels.

  • Handson proactive selfreliant working style with high attention to detail.

  • Ability to thrive in a fastpaced environment with shifting priorities.

  • Experience in Womens Health is desirable.

  • Strong communication skills in English both written and verbal.

About the Role

In this position you will:

  • Act as the global medical safety expert for all Theramex products.

  • Lead Safety Monitoring Committee decisionmaking.

  • Drive signal detection riskmanagement activities and prioritisation of mitigation strategies.

  • Contribute to scientific evaluation of varied safety data sources.

  • Author and/or review safety content for regulatory and clinical documents (PSURs RMPs SmPCs PILs protocols HA responses).

  • Contribute to benefitrisk analyses across the portfolio.

  • Maintain high standards of compliance with global pharmacovigilance regulations.

  • Produce clear fitforpurpose signal evaluation documents for internal and external audiences.

  • Interpret epidemiological and safety data to support product differentiation and informed decisionmaking.

  • Deliver training on safety or medical topics where needed.

  • Review and medically assess individual case safety reports.

  • Act as medical point of contact for the EU/UK QPPV or Deputy in cases of emerging safety concerns.

What does our team say about life at Theramex

Theramex is committed to womens health and is making a huge positive impact to womens lives. I feel this daily in my interactions in the field. It fuels my passion to contribute as I can see feel and hear the impact in my area. How does it make me feel Empowered and proud!

Claire Holmes Womens Health Account Manager

Why Join Us

Be part of a dynamic team at Theramex where youll have the opportunity to make a significant impact on womens health. We offer:

  • A fastpaced environment with broad exposure where you can develop professionally even outside your area of expertise.

  • A culture that supports growth encourages learning and celebrates success.

  • Opportunities for driven and talented professionals who want to be part of our purposedriven journey.

Apply Now!

If youre passionate about making a difference and meet the qualifications wed love to hear from you. Apply today to join our team at Theramex.

The Pharmacovigilance Physician will provide medical and clinical expertise strategic oversight and handson support to ensure robust safety surveillance and riskmanagement compliance across all Theramex products. Acting as the global medical safety expert this role leads safety governance drives sig...
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Key Skills

  • EMR Systems
  • Post Residency Experience
  • Occupational Health Experience
  • Pain Management
  • SOAP
  • Primary Care Experience
  • Medical Management
  • Suturing
  • Workers' Compensation Law
  • Pharmacy Residency
  • Botox Experience
  • Epic

About Company

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We are Theramex, a global specialty pharmaceutical company solely committed to supporting the health needs of women through every stage of life.Wework closely with our partners, healthcare professionals, and patients to help women find the solution that may be right for them at the ti ... View more

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