PV Project Manager and Deputy QPPV – 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 PV Project Manager and Deputy QPPV.
Position Summary
The Pharmacovigilance (PV) Project Manager and Deputy QPPV will report directly to the Corporate Drug Safety Manager, QPPV & Vigilance MD Responsible Person, playing a strategic role in supporting the oversight, maintenance, and continuous improvement of the global Pharmacovigilance system, ensuring full compliance with applicable Swiss, EU and international regulations.
Key Responsibilities
- Lead and coordinate Pharmacovigilance projects, ensuring timely delivery and alignment with business and regulatory requirements.
- Act as Deputy QPPV, ensuring continuity of Pharmacovigilance operations, regulatory compliance, and appropriate oversight during periods of QPPV absence.
- Oversee global Pharmacovigilance system activities, ensuring compliance with Swiss, EU, and international regulations.
- Support the maintenance of Swiss and Global Pharmacovigilance System Master File (PSMF), coordinating input from internal functions and external partners.
- Lead signal management activities and contribute to the benefit-risk evaluation of Company’s products.
- Coordinate safety communications including Direct Healthcare Professional Communications (DHPCs).
- Oversee the preparation and submission of aggregate safety reports (PSUR/PBRER, DSUR).
- Ensure end-to-end oversight of adverse event collection, assessment and reporting from all sources (spontaneous reports, clinical trials, literature, partners).
- Maintain strong collaboration with the affiliate, commercial partners and external vendors to ensure global PV compliance.
- Oversee the Global Safety Database and support system maintenance, upgrades and configuration activities.
- Monitor regulatory intelligence and ensure compliance with EudraVigilance and other applicable reporting requirements.
- Support the development, review, and maintenance of SOPs and controlled PV documentation.
- Ensure inspection readiness and contribute to continuous improvement of the PV system across the product lifecycle (pre- and post-authorization activities).
Qualifications and skills
- Master’s degree or PhD in a scientific or healthcare discipline (e.g. Pharmacy, Medicine, Biology, Chemistry or related field).
- At least 5–8 years of experience in Pharmacovigilance within a pharmaceutical company or CRO.
- Strong knowledge of EU GVP modules, ICH guidelines, Swiss and global PV regulations.
- Previous experience as Deputy QPPV or in a senior PV role is strongly preferred.
- Experience with signal management, aggregate reporting, PSMF, and safety databases (e.g. Veeva Vault Safety).
- Solid experience in PV project management and cross-functional coordination.
- Excellent command of written and spoken Italian and English; French is a plus.
- Familiarity with regulatory inspections and compliance processes is an advantage.
Preference will be given to candidates based in Switzerland.
We offer
Fulltime permanent employment in a dynamic and scientifically driven working environment.
Sintetica promotes diversity and gender equality.