Pharmacovigilance Specialist (d/f/m)

Job content

• Detail-oriented teamplayer|12-months contract with extension option

About Our ClientWe are currently recruiting for our client, a leading international company active in the pharmaceutical sector, with modern offices in the canton of Lucerne, a Pharmacovigilance (PV) Specialist in a temporary position starting in September for the next 12 months, with the option of extension or take-over. Hybrid working model.Job DescriptionIn this position the selected candidate will be responsible for the following task area:

• Day-to-day adverse events case management including case intake, tracking, translation to English (as applicable), acknowledgments, and follow-up activities in accordance with PV procedures and country regulations.
• Reporting adverse experiences or events (AE) or product quality complaints (PQCs) associated with the use of our company products in compliance with Corporate Policy 01: Patient Safety.
• Coordinating translation of PV documents and ensure a QC check is performed by a second person for any in-house translations (as applicable).
• Completing all required/applicable trainings assigned at time of hire and after hire by the due dates, before performing the activity.
• As assigned by PV Lead, scheduling and coordinating submission activities for PSURs and other Aggregate Reporting to the local Health Authority in compliance with company procedures and local legislation (as applicable).
• Filing, storing and archiving safety-related and regulatory data and documentation in accordance with department and company policies and local requirements.

Depending on the PV experience of the candidate, further activities may be delegated, such as:

• Execution of local PV processes and activities in collaboration with internal functional areas and external parties as assigned.
• Support of local PV audits and inspections including readiness activities and supports audits of business partners/vendors including the development of CAPAs in response to findings/observations as assigned.
• Support of PV Lead in maintaining the local PV Training matrix and onboarding plans.
• Support development and maintenance of local PV controlled documents (i.e., Company Core Pharmacovigilance Documents, training materials, etc. as applicable) ensuring that they are kept current.
• Support of training of local company staff, distributors, vendors, and business partners as instructed by their manager.
• Managing and performing local literature screening and assessment in accordance with company procedure and local requirements (as applicable).
• Responsibility for Health Authority Website Monitoring for potential safety issues, safety alerts, and new/revised PV requirements in compliance with company procedures and local legislation (as applicable).
• Ensuring appropriate PV language is included in country PV agreements, liaising with business partners, vendors and Alliance Managers as required, performing local qualification/due diligence activities, compliance reviews, and ensuring maintenance of the business partner data tracking system.
• Reviewing, providing input and approving local initiatives (e.g., digital interfaces, marketing initiatives/ patient programs, organized data collection systems, etc.), and other programs to ensure compliance with PV requirements, as applicable.
• Ensuring appropriate implementation and oversight of Risk Minimization Measures and Additional Risk Minimization Measures locally as per department policy and local legislations.
• Support of local implementation of applicable business continuity plans (as applicable)
• Being the local Subject Matter Expert on relevant PV regulations, processes, and procedures.

The Successful ApplicantIn order to be considered for the role, the selected candidate must have:

• Health, life science, or medical science degree or equivalent by education/experience
• Experience in the pharmaceutical industry is preferred
• General knowledge of AE reporting requirements and relevant PV regulations is preferred, but is not required
• Fluency in English and German (B2) are a MUST. French (Italian) skills is a plus.
• Ability to interface broadly with colleagues within related functions and cross-functionally and to work independently with no supervision except in the most complex of situations

What’s on OfferGet your foot into a renowned company in the pharmaceutical industry. Hybrid working model.Contact: Kamila FotiouQuote job ref: JN-072023-6117435