LOCAL MEDICAL SAFETY SPECIALIST (MATERNITY COVER)

At Johnson & Johnson, we believe health is everything.
Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal.
Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.
Learn more at https://www.
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The position is a temporary contract position as a maternity leave cover.
You will be working in our hybrid model from our office in Bucharest.
Role Overview Support activities related to safety reporting requirements as required by Marketing Authorization Holders (MAH) and/or study sponsor, as applicable.
The Local Safety Specialist provides support to the Local Safety Officer in all aspects of Safety Management and Reporting at the Local Operating Company level.
Key responsibilities.
Establish Product knowledge with focus on safety profiles, Therapeutic Area 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 implementation of Risk Management Plans, Urgent Safety Restrictions and DHPCs, if required; Participate in meetings with relevant collaborators 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 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 legislations 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.
Scientific/ life-science background, medicinal knowledge preferred; proficiency in Medical terminology (Romanian and English languages).
Awareness of and familiarity with industry principles of drug development and pharmacology Good verbal and written communication skills, fluency in Romanian and English languages is required.
Ability to negotiate and connect with internal and external customers.
Ability to establish and maintain open relationships within the partners.
Demonstrable knowledge of all local PV requirements and of Global aspects of drug safety.
Experience Experience in pharmaceutical regulations and R&D processes.
Minimum 3 years experience in Pharmacovigilance Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment.
Please contact us to request accommodation.