Firmenprofil
Our client is a renowned biotech company with modern offices in Zug, dedicated to innovation and excellence in pharmaceutical development and patient care. They are committed to upholding the highest standards in safety and compliance.
12 months contract with take‑over option.
Aufgabengebiet
As PV expert (a) your responsibilities fall in the following area:
* Lead the end‑to‑end signal management process for assigned products, including detection, tracking, evaluation, documentation and risk assessment of safety signals.
* Analyse and integrate safety data from multiple sources and author comprehensive signal evaluation reports.
* Chair Safety Signaling Team meetings and oversee the periodic review process.
* Manage literature surveillance to identify and assess relevant safety information.
* Act as key point of contact for regulatory authorities, leading responses to safety‑related queries.
* Own and drive aggregate safety reporting, including strategy, review and finalisation (e.g. PSURs, DSURs, RMPs, REMS, PV Plans).
* Collaborate cross‑functionally with Global Safety Officers, Medical Leads and Clinical teams on investigational programmes, including protocol/ICF review, safety committees, data analysis and ad hoc requests.
Anforderungsprofil
* Degree in Life Sciences, Healthcare or related field; advanced degree (PhD, MPH, PharmD, etc.) preferred depending on experience.
* ≥7 years experience in Pharmacovigilance, including signal management and aggregate safety reporting.
* Strong ability to interpret, analyse and communicate medical and scientific data effectively (written & verbal).
* Proven ability to independently lead complex PV activities (e.g. signal evaluation, regulatory responses, aggregate reports).
* Solid understanding of drug development and global safety regulations (clinical and post‑marketing), including case processing and expedited reporting.
* Proficiency in standard tools (Excel, PowerPoint, Word) and safety databases.
* Collaborative mindset with demonstrated ability to work cross‑functionally and lead within matrix environments.
* Strong clinical judgement and decision‑making capabilities.
* Excellent organisational skills with ability to prioritise and work autonomously.
Vergütungspaket
* Opportunities to work with a respected organization in the LIFE SCIENCE sector.
* A collaborative work environment that values expertise and innovation.
* Exposure to international regulatory frameworks and best practices in pharmacovigilance.
* Remote work possible if you are based in CH.
If you are passionate about contributing to the safety of pharmaceutical products and possess the required expertise, we encourage you to apply for the PV Expert role today!
Kontakt
Referenznummer: JN-052026-7025433
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