Director, Pv Operations

vor 3 Monaten

Basel, Schweiz VECTURA FERTIN PHARMA Vollzeit

Contract Type: Permanent

Closing date:
Reference: VN1884
- Who We Are

Vectura Fertin Pharma’s ambition is to become a market-leading wellness and healthcare business. Formed in March 2022, the business brings together two unique organizations: Vectura, experts in inhalation technology and Fertin Pharma, experts in oral and intra-oral delivery systems.

We are driven by the exciting and unique goal of addressing unmet patient and consumer needs by revitalizing, repurposing, and reimagining existing therapies to better serve people in taking care of their health and wellbeing.

What We Will Deliver

We focus on the development of a proprietary pipeline of wellness and healthcare products, with a specific focus on highly differentiated products that address unmet medical and consumer needs.

By leveraging our unique and enabling R&D capabilities, we are building a pipeline that includes inhalable medicines and consumer wellness products.

About the role:
As Pharmacovigilance Operations Director, you will be reporting to the Head of Safety and working in close links with the safety, regulatory, clinical and medical functions, the Chief Medical Officer as well as other relevant functions throughout the organization.

As Pharmacovigilance Operations Director, you will play a critical role in ensuring the safety and well-being of patients using our pharmaceutical, healthcare and wellness products worldwide. You’ll oversee activities and processes related to pharmacovigilance system of the company. Your expertise will contribute to the overall success of the company’s operating model.

Core responsibilities:

- Develop and execute the Pharmacovigilance (PV) system strategy aligned with regulatory requirements and company goals.
- Establish processes and provide oversight to ensure adequate collection, processing, expedited reporting of Individual Case Safety Reports associated with our products.
- Lead the PV system setup activities across the company and provide strategic guidance on matters related to safety database, activities linked to post-marketing requirements, such as Qualified Person Responsible for Pharmacovigilance, Local Safety Points of Contact, and PV System Master File.
- Contribute to the development of quality management system through implementation of appropriate SOPs, processes, key performance metrics, and training at a global level.
- Lead PV relationships with PV vendor(s) and ensure compliance with relevant Service Level Agreements and Pharmacovigilance Agreements.
- Provide strategic input to PV-related projects and resourcing decisions to effectively meet safety objectives.
- Participate in audits/inspections as Subject Matter Expert (SME).
- Foster a culture of excellence, continuous learning, and collaboration.

Role Requirements:

- Advanced life-science degree with minimum 10 years of PV experience, including hands-on experience in management of PV vendors and Contract Research Organizations.
- Significant experience in developing PV agreements and collaborating with Qualified Persons for Pharmacovigilance (QPPVs) and local Safety Points of Contact.
- Extensive experience in PV inspections, including serving as an SME with direct interaction with inspectors.
- In-depth understanding of global pharmacovigilance regulations (ICH, FDA, EMA, etc.)
- Broad experience from previous roles involving consumer health, OTC as well as prescription products and advantage.
- Strong leadership, communication, and decision-making abilities.
- Ability to work effectively with cross-functional teams and external partners.
- Demonstrated ability to communicate strategy, issues, and risks in written and verbal format.
- Ability to handle ambiguity, short deadlines and fast changing environment.
- Proven capabilities working in a matrix organization.

Why Join Us?

We are bound by our shared passion for making a positive impact on the lives of patients and consumers. Vectura Fertin Pharma is a place where you can help shape the future of healthcare, where we collaborate, support, and inspire each other to achieve the best outcomes. As a growing business, we can offer a wealth of opportunity to develop your career both locally and in international settings.

We embrace hybrid and flexible working and are centered on delivering a ‘purpose-driven’ experience for all our employees.

**Basel, Switzerland**:
Messeplatz 10
CH-4058
Basel
Switzerland

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