Pharmacovigilance Affiliate Drug Safety Associate - Alpine

Job description:

About this Job:

As Pharmacovigilance Affiliate Drug Safety Associate, you will be an essential member of the team at our Alpine affiliate (Austria, Liechtenstein, and Switzerland), with a primary focus of around 80% on Switzerland. In addition to ensuring day-to-day operations, you will act as Deputy Local QPPV (L-QPPV) for Switzerland and Deputy Drug Safety Officer (DSO) for Austria.

Key Responsibilities:

• Business continuity, quality and compliance for local PV tasks and responsibilities
• Local case processing, local literature review
• Interactions with Swissmedic regarding drug safety signals
• Implementation of additional Risk Minimization Measures
• Quality Management System (e.g., audits / inspections, third party life-cycle management)

Required profile:

Essential Knowledge & Experience:

• Previous experience in PV or a PV role combined with RA and/or QA
• Experience with local case processing activities in a safety database (ICH E2B format) preferred
• Ability to work independently, result-oriented, adept at meeting timelines while effectively managing fluctuating workloads
• Proficient with Microsoft Office applications

• BA/BS (Pharmacy, Medical or Biomedical/Life Sciences preferred), or equivalent
• Familiar with current local and regional PV regulations/guidelines
• Quality mindset, adequate understanding of GxP Quality Management System requirements
• Good communication and collaboration skills
• Proficiency in German (native speaker) and English (min. level C1), preferably in combination with French and/or Italian (min. level B2)

What we offer:

Additional information:

• This is a permanent, full-time position.
• Location: Switzerland (Zurich/Wallisellen)
• This position follows our hybrid working model. Role requires a blend of home and a minimum of 2 days per week in our office. Flexibility may be required in line with business needs. Candidates must be located within a commutable distance of the office.
• Flexible availability (e.g., during summer holidays) is preferred given the role of Deputy.