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Local Safety Specialist, Romania (2-year contract) - 2406201156W

Description

The Johnson & Johnson Family of Companies

A global leader in health and personal care, with over 125,000 employees in over 275 companies in 60 countries. We work with healthcare partners to touch the lives of more than a billion people every day worldwide.

“By caring, one person at a time, we aspire to help billions of people live longer, healthier, happier lives.”

Johnson & Johnson Innovative Medicine is recruiting for a Local Medical Safety Specialist, located in our Bucharest office. This position will work in a hybrid home/office model. This position is a temporary role with a two-year contract.

In this role, you will support our activities related to safety reporting requirements as required by Marketing Authorization Holders (MAH) and/or study sponsors. Besides this, you will also support the Local Safety Officer in all aspects of Safety Management and Reporting at the country level.

Key responsibilities:

• Establish Product knowledge with a focus on safety profiles, Therapeutic Areas and Disease Pathway knowledge supporting the needs of the local Medical and Marketing organization in collaboration with the Subject Matter Experts and the Local Safety Officer (LSO);

• Act as safety expert in cross-functional team meetings and perform training on safety-relevant aspects, as appropriate;

• Involvement in the implementation of Risk Management Plans, Urgent Safety Restrictions, and DHPCs, if required;

• Participate in meetings with relevant colleagues for discussion and evaluation of topics related to benefit-risk and product safety as required;

• Medical/ pharmaceutical assessment of local individual cases when requested in partnership with global teams, as appropriate;

• Perform Pharmacovigilance training for Local Operating Company employees and local partners;

• Manage local PVAs, ensure local implementation and oversight

• Support the review of new/revised safety regulations (for drugs and non-medicinal products in the scope of responsibilities), evaluation of the impact on local processes, and notification of appropriate global and regional groups via central PV policy tracker about changes in local regulatory safety including cosmetics and medical device safety reporting requirements

• Ensure implementation of new legislation with local impact for IPV-owned activities, depending on topics

• Collaborate with local and regional teams to ensure Local Operating Company/ Local Safety Unit audit and inspection readiness

Qualifications

Our Requirements:

• Experience in pharmaceutical regulations and R&D processes.

• Minimum 3 years experience in Pharmacovigilance

• Scientific/ life-science background, medicinal knowledge preferred; proficiency in Medical terminology

• Awareness of and familiarity with industry principles of drug development and pharmacology

• Good verbal and written communication skills and proficiency in Romanian and English languages are required.

• Ability to negotiate and communicate with internal and external customers. Ability to establish and maintain open relationships with collaborators.

• Proven knowledge of all local PV requirements and of Global aspects of drug safety.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, perform essential job functions, and receive other benefits and privileges of employment. Please contact us to request an accommodation.

Primary Location Europe/Middle East/Africa-Romania-Bucuresti-Bucharest

Organization JOHNSON & JOHNSON ROMANIA S.R.L. (7159)

Job Function Pharmacovigilance

Req ID: 2406201156W