Pharmacovigilance Country Lead for Romania and Bulgaria and Local Contact Person for Pharmacovigilance (LCPPV) in Romania

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Job Description

At our heart we are committed colleagues. We offer interested people numerous opportunities and strongly believe in, and promote, diversity, equity, and inclusion. As a company we offer roles based on merit, welcoming candidates of any gender, age, religious belief, sexual orientation, race, color, ethnic or social origin, or disability.

Our team is growing and for this we need bright minds with creativity and flexibility – what talent do you have?

At Takeda, our Patient Safety & Pharmacovigilance (PSPV) team plays a vital role in protecting patients and ensuring the safe use of our medicines. As Pharmacovigilance Country Lead for Romania and Bulgaria and Local Contact Person for Pharmacovigilance (LCPPV) inRomania, you will provide leadership and expertise for local pharmacovigilance operations while ensuring compliance with local and global regulatory requirements.

Working closely with colleagues across Eastern Europe cluster and global Patient Safety & Pharmacovigilance teams, you will help implement safety strategies, strengthen compliance, and maintain an effective pharmacovigilance system that puts patients first.

How You Will Contribute

• Serve as the appointed Local Contact Person for Pharmacovigilance (LCPPV) in Romania and act as the primary contact for National Competent Authority (NCA) on pharmacovigilance matters.

• Be the point of contact for Romania and Bulgaria PV related matters for PSPV and in front of the NCA, including audits and inspections.

• Manage and oversee the pharmacovigilance system and activities across Romania and Bulgaria, ensuring compliance with local regulations, global procedures, quality standards, and business continuity requirements.

• Provide pharmacovigilance expertise and guidance to medical and commercial team engagements (including but not limited to organized data collection such as PSP, MR, NIS, early access, suppliers with PV obligations, agreements, PV training, Risk Management Plans and applicable implementation of aRMMs). This includes working with local or global PV suppliers where appropriate and ensuring a common understanding of the distribution of PV responsibilities and oversight is put in place.

• Collaborate across the Eastern Europe cluster with global, regional, and local PV teams - including the EU QPPV office - to support countries needs, implement PV strategies, facilitate cross-functional communication, and assist colleagues as needed.

• As an SME, build and maintain strong relationships with internal and external stakeholders to support effective safety governance and collaboration.

• Act as the local subject matter expert for pharmacovigilance regulations, compliance requirements, and operational processes, identifying risks and leading corrective and preventive actions where required.

• Support audits, inspections, compliance activities, and continuous improvement initiatives across the region.

• Contribute to pharmacovigilance projects across the Eastern Europe cluster and provide deputy support to other PV Country Leads when required.

• Promote Takeda’s values of “Patient, Trust, Reputation and Business” through collaboration, integrity, and operational excellence.

What You Bring to Takeda

• Bachelor’s degree or higher in Life Sciences, Pharmacy, Medicine, Nursing, or another relevant healthcare discipline. An advanced degree is an advantage.

• Minimum 5 years of experience in pharmacovigilance or a related regulated healthcare environment, gained at local, regional, or global level.

• Eligibility to fulfil all local LCPPV requirements in Romania, including relevant education, training, residency, language, and experience requirements.

• Excellent knowledge of post-marketing pharmacovigilance regulations and applicable healthcare legislation.

• Solid understanding of medical and scientific terminology.

• Fluency in Romanian and English.

• Proven ability to work effectively across functions and influence stakeholders in a matrix organisation, also within virtual teams.

• Well-developed organisational skills, attention to detail, and the ability to manage multiple priorities in a regulated environment.

• High level of computer literacy and commitment to quality documentation practices.

• Team worker with collaborative approach, flexible mindset, high degree of cross-cultural awareness and a passion for improving patient safety.

Empowering our people to shine

At Takeda, we earn the trust of society and our customers through our values of Takeda-ism: Integrity, Fairness, Honesty, Perseverance. We incorporate these values in everything we do. They represent who we are and how we act. They help us make decisions that we can be proud of today and in the future. We enable our employees to develop their full potential. As a global top employer, we offer exciting career paths, promote innovation, and strive for top performance in everything we do. Takeda fosters an inclusive, collaborative, and international work environment where our teams are united by their relentless commitment to our goal of improving people's health and creating a better future for the world.

Diversity, Equality, and Inclusion

Takeda is committed to foster diversity, equality, and inclusion. Hiring decisions are based entirely on qualifications and are made regardless of gender, ethnic origin, religion, sexual orientation, age, or disability.

If you are interested in this opportunity, we look forward to receiving your application via our online tool!

Learn more at takedajobs.com

Locations

ROU - Bucharest

Base Salary Range:

L228,000.00 - L313,500.00

For information about our benefits, please click here.

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time