Senior PV Scientist - #45763

Job Description

• 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 company 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.