Stellenbeschreibung:
Aktuelle Karriere-Informationen von Swisslinx AG für die Position als Senior PV Scientist. If the Senior PV Scientist Stellenangebot in Zürich Ihren Qualifikationen entspricht, reichen Sie Ihre Bewerbung bitte direkt über das aktualisierte Jobkos-Portal ein.
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Senior PV Scientist
For our client in the biotechnology industry, we are looking for a Senior Pharmacovigilance Scientist to lead global product safety and signal management activities.
Senior PV Scientist
Stellenbeschreibung:
Lead pharmacovigilance activities for assigned products across clinical development and post-marketing phases.
Manage and oversee safety signal detection, evaluation, tracking, and documentation processes.
Author and review signal evaluation reports and aggregate safety reports including PSURs, DSURs, RMPs, and related documentation.
Support responses to regulatory authority safety requests and inquiries.
Collaborate cross-functionally with Clinical Development, Regulatory Affairs, Medical Affairs, and Safety teams.
Contribute to clinical trial safety activities, including protocol reviews, informed consent reviews, and safety committee participation.
Review scientific and medical literature for relevant safety information.
Provide expertise on global pharmacovigilance regulations and safety processes.
Support ongoing compliance and maintenance of product safety standards globally.
About the customer:
Our client is a globally operating organization within the life sciences sector, focused on developing innovative therapies that improve patient outcomes worldwide. The Unternehmen combines scientific excellence with a collaborative and patient-centric culture, offering professionals the opportunity to contribute to impactful healthcare solutions in an international environment.
Requirements:
Bachelor’s degree in Life Sciences, Pharmacy, Medicine, Biology, or a related scientific discipline; advanced degree preferred (PhD, PharmD, MPH, NP, etc.).
Minimum 7 years of Pharmacovigilance / Drug Safety experience within the biotechnology, pharmaceutical, or life sciences industry.
Strong experience with safety signal management, including signal detection, evaluation, tracking, and documentation.
Hands-on experience authoring and reviewing aggregate safety reports such as PSURs, DSURs, RMPs, and REMS.
Solid understanding of global pharmacovigilance regulations, clinical trial safety regulations, and post-marketing safety requirements.
Experience with safety data analysis, benefit-risk evaluation, and safety surveillance activities.
Knowledge of case processing, expedited reporting requirements, and pharmacovigilance operations.
Experience working with safety databases and tools such as Argus, ArisG, MedDRA, Business Objects, Excel, and other PV systems.
Ability to interpret and communicate scientific and medical safety data clearly and effectively.
Strong cross-functional collaboration skills with teams such as Clinical Development, Medical Affairs, Clinical Operations, and Regulatory Affairs.
Please note that only candidates with a valid Swiss work permit or EU/EFTA citizenship can be considered for this Position.
Excellent stakeholder management, organizational, and project coordination skills.
Fluent English communication skills, both written and verbal.
Ability to work independently in a fast-paced, global environment. jid493be2bws jit0522ws jiy26ws
Job-Informationen:
- Unternehmen: Swisslinx AG
- Position: Senior PV Scientist
- Arbeitsort: Zürich
- Land: CH
So bewerben Sie sich:
Nachdem Sie die Kriterien und Mindestanforderungen in der Stellenanzeige gelesen und verstanden haben, Senior PV Scientist at the office Zürich bereiten Sie bitte umgehend Ihre Bewerbungsunterlagen (Anschreiben, Lebenslauf, Zeugnisse) vor. Senden Sie diese über den Link 'Nächste Seite' unten ein.
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