Pharmacovigilance (PVG) Strategy Manager

A Career with Purpose

Bionical Emas is a global Early Access Programs (EAP) and Clinical Trial Supply (CTS) group bringing life-changing medicines to patients around the world. Their range of services and capabilities benefit many of the world’s leading pharma and biotech companies.

At Bionical Emas, you will have the chance to develop your career while working with an outstanding team of people. Our shared values create a unique culture that guides our actions and defines who we are. You will be a part of a welcoming, flexible, and supportive culture that values trust and belonging. We believe that creating opportunities for our people to develop their skills is crucial to our growth and success. If you are inspired by changing the lives of patients all over the world, we’d love to hear from you.

About the Role

We are looking for a Pharmacovigilance Strategy Manager to be responsible for leading the development, implementation, and ongoing evolution of pharmacovigilance strategies to support the delivery of Early Access Programs (EAP), Post Trial Access (PTA) and Real-World Data Collection (RWD)

Operating at the intersection of strategic pharmacovigilance, client engagement, program design, compliance oversight, and business development, the Pharmacovigilance Strategy Manager will develop pragmatic, compliant, and scalable pharmacovigilance solutions that enable patient access while meeting diverse global regulatory requirements.

What will your job look like?

• Strategic pharmacovigilance leadership: Design and implement scalable PV oversight models aligned with programme objectives, client expectations, and global regulatory requirements, and contribute to new PV service offerings that strengthen Bionical’s position in Early Access.

• Regulatory and access intelligence: Provide strategic guidance on safety reporting obligations, governance frameworks, and country-specific requirements, and monitor the global access environment to turn regulatory developments into practical programme strategies.

• Programme lifecycle and change management: Assess PV requirements for geographic expansion, new access routes, and changing patient populations, and manage safety-related change to maintain compliance with minimal disruption.

• Programme close-out: Oversee close-out planning, final assessments, reconciliation, document retention, vendor offboarding, lessons learned, and improvement actions.

• Client partnership and business development: Partner with Business Development to design tailored PV solutions and support proposals, and act as the primary strategic PV contact and trusted advisor for assigned client accounts, with a clear understanding of their risk tolerance, priorities, and commercial objectives.

• Stakeholder management: Build effective relationships with internal teams, clients, vendors, regulators, ethics committees/IRBs, and programme partners, and influence cross-functional groups (Project Management, Patient Access, Quality, Regulatory, Medical Affairs, Commercial, Legal) to drive alignment and resolve issues.

• Vendor oversight and governance: Establish vendor oversight frameworks, communication pathways, performance expectations, and escalation processes, and monitor vendor compliance, quality metrics, deviations, CAPAs, and audit outcomes against regulatory and contractual requirements.

• Compliance and inspection readiness: Oversee programme-level PV compliance, systems, agreements, documentation, and traceability, identify and mitigate safety, process, and quality risks, and support inspection readiness and regulatory authority interactions.

• Safety reporting management: Define country- and programme-specific strategies for individual and aggregate reporting, and oversee the preparation, review, and submission of aggregate and periodic reports, line listings, and safety summaries.

• Operational governance: Provide strategic oversight of programme implementation and ongoing safety management, and develop Safety Management Plans, Pharmacovigilance Agreements, and scalable governance, quality, and procedural frameworks.

What will you need to succeed?

• A bachelors or similar degree within the life sciences would be advantageous

• Extensive pharmacovigilance experience within a global pharmaceutical, biotechnology, or life sciences environment

• Experience supporting Early Access, Managed Access, Compassionate Use, Named Patient, or similar patient access programmes

• Proven ability to develop and implement pharmacovigilance frameworks across multiple regions in line with regulatory, reporting, and compliance requirements

• Experience acting as a senior pharmacovigilance representative for clients, programmes, or strategic initiatives

• Experience contributing strategic expertise to commercial or business development activities

• Experience managing vendors, inspections, audits, quality systems, and cross-functional stakeholder relationships

What will you get in return?

We want you to do your best work! We care about our people’s well-being, their personal development and providing a true work-life balance. Our benefits are aligned with our culture and values and are intended to maximize your experience working for us. Here are some of the benefits you can expect from working for Bionical Emas.

• 25 days of vacation

• Vacation days purchasing scheme

• 1 extra vacation day per each 3 years of service

• Discretionary Annual Bonus

• Sabbatical of 3 to 6 months (after 2 years of service)

• Free food and beverages at all offices

• Life Insurance

• Health Insurance and Employee Assistance Programme

• Employee Support Networks – help us continue to build on our inclusive culture

• Flexible and hybrid work

Does this sound like you?

It is time to apply, and we can’t wait to hear from you!

Even if you don't meet 100% of the requirements, be confident in yourself and don't hesitate to apply!

PLEASE NOTE: We will be longlisting applications as soon as we receive them, so please apply early to register your interest.

We Are Bionical Emas

We are proud of our people and proud of our achievements. We encourage and hire people with diverse backgrounds, voices, beliefs, and perspectives into our growing global workforce. We do not discriminate on the basis of actual or perceived race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth, and pregnancy-related conditions), gender identity or expression (including transgender status), sexual orientation, marital status, military service and veteran status, physical or mental disability, genetic information, or any other characteristic protected by applicable federal, state or local laws and ordinances. Bionical Emas’ management team is dedicated to this policy with respect to recruitment, hiring, placement, promotion, transfer, training, compensation, benefits, employee activities, access to facilities and programs, and general treatment during employment.

Bionical Emas offers equal opportunities and is committed to diversity in its workplace and providing accessibility accommodations to applicants with physical and/or mental disabilities. If you are interested in applying for employment with Bionical Emas and need accommodation or special assistance, please let us know by sending an email with your request to the recruitment team at HR@bionicalemas.com.

We Are Bionical Emas, where each person is unique. We celebrate individuality while encouraging our talents to work as a team. Together, we make a difference by powering an inclusive future for all. Be you, with us.

Protecting your privacy and the security of your data is a longstanding top priority for us. Please consult our Privacy Notice to know more about how we collect, use, and transfer the personal data of our candidates. Our Privacy Notice explains what personal information we may process, where we may process your personal information, our purposes for processing your personal information, and the rights you can exercise over Bionical Emas’ use of your personal information. By applying for the above position, you confirm that you have reviewed and agreed to our Data Privacy Notice for Candidates: Privacy Policy - Bionical Emas applicable to your place of residence.

Powering the patient journey