Mission
The Pharmacovigilance Officer performs activities to support the Qualified Person Responsible for Pharmacovigilance in relation to Pharmacovigilance, Postmarket Surveillance and Medical Device Vigilance, and Cosmetovigilance, as required. Under the supervision of the QPPV and the Senior Pharmacovigilance Manager & Deputy QPPV or Senior Pharmacovigilance Manager, the PV Officer has the responsibility and authority for establishing and maintaining the marketing authorisation holder’s pharmacovigilance system for the company. Pharmacovigilance Officer is also involved in Medical Device Vigilance and Cosmetovigilance.
Responsibilities
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Maintain a global overview of the safety profile for the Ferrer products under their responsibility and keep the Company’s Pharmacovigilance System Master File (PSMF) up to date.
- Collection, management, and submission of safety information for medicinal products, medical devices, and cosmetics (e.g., adverse events, periodic safety update reports, risk management plans, etc.) to the competent authorities.
- Detection and management of signals that may impact the benefit-risk balance of the product.
- Drafting and reviewing pharmacovigilance agreements (SDEA/PVAs) with third-party companies.
- Pharmacovigilance training for all Ferrer employees.
- Creation and updating of Standard Operating Procedures (SOPs) and other documents and collaborating with the Quality Assurance (QA) Department in conducting internal and third-party audits.
- Management of Key Performance Indicators (KPIs).
Why Ferrer?
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Make a positive impact in society
- Participate in volunteering activities
- Grow in a culture of trust, responsibility, and constructive feedback
- Enjoy a flexible working model & collaborative office experience to enable innovation and teamworking
- Make a real difference to the team and to yourself
- Take advantage of opportunities for development & learning
- Discover a range of benefits to support your physical, emotional and financial wellbeing
- Customize your remuneration and benefit
What you’ll need to succeed
You will rock at this company and role if you are a person with empathy, humility, curiosity and optimism.
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Degree in Health Sciences.
- Minimum 3 years of experience in Pharmacovigilance.
- Knowledge of GVP and EU/Worldwide Pharmacovigilance regulatory requirements.
- Fluent English, written and spoken.
- Strong organisational, analytical and communication skills.
- Ability to work cross-functionally, manage stakeholders and take decisions.
If this great challenge matches your profile, then we are waiting for you!
At Ferrer, we guarantee equal treatment and opportunities in recruitment, avoiding prejudices and stereotypes for any reason in the processes of access to the company, assessing only objective criteria such as professional and academic skills and work experience.