Pharmacovigilance Officer

Location: Barcelona (Spain)
Sector: Pharmaceutical and biopharmaceutical
Vacancies: 1
Work modality: Hybrid

Grupo Ferrer Internacional

At Ferrer we use business to fight for social justice. We have long been a company that looks to do things differently; instead of maximizing shareholder returns, we reinvest much of our profit in initiatives that give back to society. Back where it belongs. We go beyond compliance and are guided by the highest standards of sustainability, ethics and integrity. As such, since 2022, we are a B Corp.

Founded in Barcelona in 1959, Ferrer offers transformative solutions for life-threatening diseases in more than one hundred countries. In line with our purpose, we have an increasing focus on pulmonary vascular and interstitial lung diseases and rare neurological disorders. Our 1,800-strong team is driven by a clear conviction: our business is not an end in itself, but a way to change lives.

We are Ferrer. Ferrer for good.

Job description

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

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?

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

Requirements

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.

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.

Location: Barcelona (Spain)
Sector: Pharmaceutical and biopharmaceutical
Vacancies: 1
Work modality: Hybrid

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