Sintetica

Pharmacovigilance Project Manager - Mendrisio site (Ticino)

Founded in 1921 and headquartered in Mendrisio (Switzerland), Sintetica's mission is to continuously strive to improve therapies by enhancing its products' formulations and usability for the benefit of clinicians and patients.

We do so in close cooperation with clinical experts, who shape our understanding of their unmet needs and drive our efforts to address them. With this trust and insight, we push the limits of science and technology to make therapies safer for patients and easier to perform. Every year we reliably supply millions of doses of our products across a range of therapeutic classes, including anaesthesia and analgesia, while expanding to address further healthcare needs.

To strengthen our Pharmacovigilance team at our headquarter in Mendrisio (Switzerland), we are currently looking for a Pharmacovigilance Project Manager.

Position summary

Under the supervision of the Drug Safety Manager, the Pharmacovigilance Project Manager will provide general support for the maintenance and continuous improvement of the PV System. He/she is responsible for leading and managing our global/regional partners and PV service provider/s. He/she will ensure compliance with company procedures, national and international regulations/standards/guidelines for pharmacovigilance.

 

Essential tasks and responsibilities

  • Acting as the primary contact point for Global/regional project-related matters
  • Oversight maintenance of clients and vendor/s monitoring the current status and results of delegated activities also through the implementation of dedicated KPIs
  • Guarantees the participation in strategic activities performed by external providers (e.g. audit, selection of local providers in EU and extra EU, etc) in order to implement a documented method to assure oversight of the PV service providers
  • Monitor and manage the workflow for assigned projects to ensure all deadlines are met and compliant with safety reporting in accordance with international reporting regulations, Standard Operating Procedures (SOPs), and local pharmacovigilance documents
  • Project activities planning
  • Drafting of Company pharmacovigilance agreements with partners, maintenance of Company’s agreement archive to guarantee adherence to the contracts and pharmacovigilance obligations
  • Conduct reconciliation activities with partners according to information sources and agreement in place
  • Maintenance of adverse event reporting requirements in all countries. Responsible for making decisions regarding adverse event reporting within the local guidelines in collaboration with local responsible persons
  • Supports development, implementation and ensures compliance of PV procedures such as Standard Operating Procedures (SOPs), Work Instructions (WIs) and guidelines, escalating any deviation from procedure where required
  • Knowledge of Eudravigilance database and related tools for submission and signal detection.

 

Knowledge and Skills

  • Degree in health sciences discipline (e.g. pharmacist, Pharmaceutical Science or related discipline)
  • At least 5 years’ pharmacovigilance experience in pharmaceutical company
  • Deep knowledge of pharmacovigilance legislation and regulations (CH/EU/GCC/LATAM)
  • Fluent in written and spoken English
  • Experience with use of safety databases and Eudravigilance tools
  • Proactivity, autonomy, precision, good teamwork skills, excellent planning skills
  • Commitment to continuous improvement

We offer

Fulltime permanent employment in a young working environment and positive culture.

Sintetica promotes diversity and gender equality.

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