Pharmacovigilance Manager - Turkiye

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:
People Leader

All Job Posting Locations:
Istanbul, Turkey

Job Description:

About Innovative Medicine

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements.

Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

Learn more at https://www.jnj.com/innovative-medicine

 

Essential Job Duties and Responsibilities

The role ensures that Safety activities across the TURGAN Cluster (Turkiye, Ukraine, Georgia and Azerbaijan) comply with local regulations, company policies, and global standards.

It also collaborates with the Cluster Safety Head in maintaining effective pharmacovigilance and risk management systems throughout the product life cycle.

Key responsibilities include, but are not limited to, the following:


* Act as back-up person for both Local Safety Officer Turkiye (local QPPV) and Ukraine (local QPPV).


* Work with Cluster Safety Head to ensure the availability of systems and processes for the collection (initial and follow-up), review, reporting, and reconciliation of Adverse Events (AEs) regardless of the sources within TURGAN cluster.


* Oversee data-generating activities to ensure that appropriate review and reporting processes are included in project documents for reporting potential Adverse Events (AEs), such as patient support programs, market research surveys, and internet sites, as applicable.


* Provide oversight of the product portfolio and establish links with local management and key stakeholders.


* Collaborate with Cluster Safety Head to oversee the safety aspects of clinical studies conducted in the territory, as applicable.


* Collaborate with Medical Affairs to review and approve the safety aspects of local study protocols or Patient Support Programs (PSP) to ensure proper safety reporting to Global Medical Safety (GMS), and Regulatory Authority (RA), as required.


* Maintain overarching responsibility for coordinating safety requirements delegated by Marketing Authorization Holders (MAH)


* Plan and ensure the timely submission of Aggregate Reports in accordance with local regulations.


* Ensure the development and implemen...