Within the Global Pharmacovigilance & Patient Safety (GPVS) department of the Hospital Care division, we are seeking a Pharmacovigilance Team Leader to be based in Timisoara and working closely with our headquarter in Germany.
GPVS is responsible for documenting, evaluating, and coordinating all activities related to the identification and management of drug safety risks in accordance with Good Pharmacovigilance Practice (GVP). In this role, you will lead the team responsible for the processing and quality oversight of Individual Case Safety Reports (ICSRs) and ensure timely, compliant case handling across all relevant global databases and systems. This position plays a key role in maintaining high-quality pharmacovigilance operations and supporting global patient safety objectives.
Tasks:
- Lead and develop a dedicated pharmacovigilance team, ensuring high-quality ICSR processing and full compliance with global PV regulations.
- Oversee the collection, evaluation, and documentation of drug safety information, including spontaneous reports, literature and authority cases, and special situations.
- Coordinate key PV activities such as literature screening, database monitoring, medical assessment, and safety-relevant data collection.
- Ensure proper use of PV systems and support updates and process improvements, including impact assessment and testing coordination.
- Ensure compliance with global pharmacovigilance regulations (GVP) and maintain audit‑ and inspection readiness.
- Serve as the primary point of contact for affiliates, consultants, and internal stakeholders in the ICSR team.
- Prepare reports, statistics, presentations, and compliance documentation, and maintain up-to-date SOPs and PV process workflows.
- Manage team performance, distribute workload, provide feedback, and support professional growth through training and mentorship.
- Contribute to resource planning, budgeting, and continuous improvement of PV processes.
- Foster a collaborative, high-performing, and inclusive team culture across a global, cross-functional environment.
Professional Competencies:
- University degree in Pharmacy or Medicine (Master’s or PhD is an advantage), or an equivalent degree in Life Sciences with a biomedical background (e.g., Pharmaceutical Sciences)
- Experience in pharmacovigilance or drug safety operations, ideally within an international environment, preferably combined with prior leadership or team coordination responsibilities and working experience in related disciplines of the pharmaceutical industry (e.g. regulatory affairs, medical sciences, quality)
- Advanced English language proficiency, both written and spoken
- Microsoft Office skills and familiarity with digital workflows and documentation systems
- Experience working in complex organizational structures, ideally with global, cross-functional teams
- Proficiency in working with databases and scientific information
Personal Qualifications:
- Authentic and accountable leader with the ability to motivate and develop teams.
- Strong sense of responsibility and commitment to patient safety and compliance.
- Goal-oriented, structured and independent working style, with strong prioritization skills.
- Excellent communication and teamwork abilities, comfortable working across cultures and locations.
- Customer-focused mindset with high-quality standards.
- Assertive, performance-driven and adaptable
- Open to continuous learning, receptive to feedback and new approaches.
- Inclusive and collaborative, valuing diverse perspectives and constructive cooperation.
Benefits:
- Global environment.
- Permanent contract and annual performance bonus.
- Flexible work: 80% remote, with office time in Sânandrei, Timis County.
- Meal tickets, health and wellness subscriptions, and family event bonuses.
- Support for eyeglasses, free coffee, and a dynamic, supportive work workplace.
- Employee-oriented and friendly working setting.
B. Braun Shared Services Romania | Adriana Nai |