Local Medical Safety Specialist - Serbia

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.jnj.com

Job Function:
Product Safety

Job Sub Function:
Pharmacovigilance

Job Category:
Scientific/Technology

All Job Posting Locations:
Belgrade, Central Serbia, Serbia, Novi Beograd, Beograd, Serbia

Job Description:

Johnson & Johnson is recruiting for a Local Medical Safety Specialist, to be based in our Belgrade office, Serbia.

This is a hybrid role, in a full-time and unlimited contract

In this role, you will promote Local Medical Safety Culture, act as our Local Safety Officer Back-up for Johnson & Johnson in our Serbian legal entity and you will be our nominated Back-up of Responsible Person for Pharmacovigilance, as applicable in accordance with internal set-up.

Your main tasks will be to ensure that all corporate requirements and local legislation on adverse reporting for medicinal products are followed, provide regular training on pharmacovigilance to all relevant employees and that the LOC PV activities are handled in compliance with local regulations and company policies.

Key responsibilities

SAFETY MANAGEMENT & REPORTING

Case processing

Key responsibility is to ensure that systems and processes are available for collection (initial and follow-up), review, reporting, and reconciliation of Adverse Events (AEs), Adverse Events combined with Product Quality Complaints (AE+PQCs), and pregnancy reports acquired through various sources, such as spontaneous, solicited, clinical trials, data generating activities, local Regulatory Authorities and more.

Translations

Translation of ICSRs, PSURs, HA correspondence, and regulatory intelligence, and other PV relevant documents when needed.

Oversight and providing input

Oversight of data-generating activities to ensure any solicitation for information includes an appropriate review and reporting process for reporting potential AEs (e.g.

patient support programs, market research surveys, internet sites), as applicable.

Assure that all vendor contracts have appropriate Pharmacovigilance language incorporated and that these contracts are archived in the global system, as applicable.

Safety oversight of clinical projects conducted in the territory as applicable.

Clinical activities compliance

Collaboration with Medical Affairs for the review and approval of safety aspects of local study protocols or Patient Support Programs (PSP) to ensure appropriate safety reporting to Global Medical Saftey or appropriate case management centre and RA, as required.

Submissio...