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 implementation of local business continuity plans (e.g., inspection readiness, Adverse Event reporting coverage).
• Ensure the satisfactory performance of day-to-day Pharmacovigilance (PV) function and maintain optimal regulatory compliance at the Local Operating Company (LOC) level.
• Support the Cluster Safety Head to ensure appropriate oversight for the implementation of Risk Management Activities for products within its responsibility.
• Take appropriate measures to ensure that new safety information is available to RA and Health Care Professionals (HCP) in a timely manner, i.e., DHPC in collaboration with adequate partners if applicable.
• Establish product knowledge with a focus on safety profiles, therapeutic area, and disease pathway knowledge to support the needs of the local Medical and Marketing organization in collaboration with the International Medical Safety leader or MSO.
• Act as a safety expert in cross-functional team meetings and conduct training on safety-relevant aspects, as appropriate.
• Support Cluster Safety Head to ensure that day-to-day PV functions and safety activities for non-medicinal products (i.e., medical devices) are performed satisfactorily, and that full regulatory compliance is maintained at Local Operating Company level.
• Manage AE/PQC training to company employees, distributors/vendors and translation of AE/PQC material, where needed.
• Provide and/ or review quarterly listings for the PSMF Annex B (vendor agreements and commercial agreements) for agreements signed by local Opco and ensure accuracy and timelines.
• Support Cluster Safety Head to ensure PV audit and inspection readiness on the LOC level continuously.
• Provide technical and strategic feedback and participate in projects/ workstreams led by the regional GMS teams.
• Ensure awareness of changes in regulations which may have an impact on vigilance activities and responsibilities.

Minimum Qualification

• A completed Bachelor’s degree in medicine or pharmacy is required.
• Proven ability to organize workflow activities and manage multiple critical issues.
• Awareness of and familiarity with industry principles of product vigilance, drug development and pharmacology.
• Expert knowledge of Global, Regional and Local Procedural Documents as applicable.
• Computer literate with knowledge of relevant IT safety systems.
• Excellent verbal and written communication skills with proven ability to negotiate and communicate with internal and external customers.
• Ability to establish and maintain open relationships within the organization and with authorities.
• Demonstrable knowledge of all local requirements and of global aspects of product safety.
• Proficiency in Turkish and English is required.
• By preference a minimum of 5 + years proven experience in a pharmaceutical company with at least 3 years in product vigilance responsibility role

Required Skills:

Preferred Skills:

Cross-Functional Collaboration, Developing Others, Global Market, Inclusive Leadership, Leadership, Medicines and Device Development and Regulation, Operations Management, Performance Measurement, Pharmacovigilance, Quality Management Systems (QMS), Regulatory Affairs Management, Report Writing, Safety Investigations, Safety-Oriented, Safety Reporting, Serious Adverse Event Reporting, Team Management

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