Position Title: Safety Officer- Deputy Country Safety Head

Job Location: İstanbul

Job Type: Permanent, Full time

At Sanofi CHC, we have one shared purpose – we work passionately, every day, to ‘serve healthier, fuller lives. Our marketing philosophy is driven by this purpose and everything we do is centered around people, our customers, healthcare professionals, and our employees, across the world.

We are building brands that serve 1bn consumers worldwide, so that they can live healthier, fuller lives. In order to do this better than anybody else, we aspire to become the most consumer-centric Fast Moving Consumer Healthcare Business. We want to be market shapers and achieve category leadership in the categories that we play in – delivered through strong global-local partnership. We are a people first business, placing consumers at the heart of everything we do through uncovering and activating deep consumer and shopper insights, for example.

As a top 3 global CHC player, we want to raise the bar in terms of our strategic and operational capabilities to enable sustainable, above-market growth. In order to achieve this, we need strong talents that will help us shape the future of CHC while sharing our core values of courage, teamwork, respect, and integrity.

Main Responsibilities:

• Supports the Country Safety Head in country related PV activities.
• Deputizes for the CSH in times of planned or unplanned absence of the CSH.
• Is nominated as deputy local Responsible Person for Pharmacovigilance (RPP) for the CHC products where applicable per national regulations.
• Supports the CSH in ensuring that local PV activities in Turkey are performed in compliance with the Global PV policies, as well as global, regional and local PV regulations to warrant safe and appropriate use of CHC products on the market in the assigned country.
• Builds close and robust relations/collaboration with the in-country partner functions, including but not limited to Medical, Regulatory, Quality, Commercial, Legal, and Country Manager.

Adverse Event (AE) Management Responsibilities:

• Ensure all necessary information is promptly collected, entered into the safety database and forwarded to the data processing unit within specified timeframes for both initial and follow-up adverse event reports.
• Responsible for the accuracy and completeness of information reported from various sources for CHC products
• Conduct follow-up activities on ICSRs as per national requirements and company standard operating procedures (SOPs).
• Responsible for timely submission of ICSRs to the Ministry of Health (MoH) in accordance with national regulations for expedited reporting.
• Responsible for ensuring reconciliation activities of case reports with business partners, and internal functions in the company are performed.

Organization and maintenance of local PV Quality system

• Support the maintenance of local quality documents owned by PV to include documented reviews, gap assessments and revisions as per global requirements.
• Support the maintenance of the local PV System Master File for Turkey as required and in accordance with local regulations and the global standards.
• Contribute to education and training on PV and relevant safety topics within the local organization.
• Maintain local compliance metrics and ensure data capture in the appropriate tools.
• Support PV process non-compliance investigation, Root Cause Analysis (RCA), Corrective Actions/Preventive Actions (CAPAs) implementation including appropriate documentation.
• Support the completion of audit and inspection observations in close interaction with Global /Local Functions

Organization and Maintenance of PV Operating System

In compliance with PV regulatory requirements and company procedures/guidelines,

• Handle appropriately local periodic reports, including periodic safety reports (PSRs) and periodic reviews, and contribute together with Global PV, Clinical Operations and RA departments to the planning for PSRs ,
• Screen local scientific / medical literature and management of relevant abstract/articles
• Support the implementation and monitor the PV requirements for global, regional and local programs (e.g. Patient Support Program, Market Research, Managed Access Program…), and company sponsored digital media
• Contribute to screening and analysis of national regulations, and forward any future/new/updated PV regulation as per defined processes
• In case of local outsourcing of PV activities to third parties (i.e. vendors/service providers/CROs), support the monitoring of the appropriate execution of outsourced activities.
• Support the Global PV and particularly the QPPV with local safety surveillance activities
• Contribute to the development of local RMP, when applicable, with the support and validation of the Risk Management Expert. Track the actual implementation of additional Risk Minimization Measures (aRMMs) in Turkey.
• Support Regional/Zone PV Lead to monitor the appropriate execution of a local or regional SDEA

Standards and Inspection Readiness

• Support the Country Safety Head in ensuring high standards of pharmacovigilance and maintaining readiness for regulatory inspections.
• Support the Country Safety Head in developing and maintaining standardized operating procedures (SOPs) for pharmacovigilance activities in Turkey in accordance with local regulatory requirements and international best practices.

JOB HOLDER REQUİREMENTS

Qualifications:

• Bachelor’s degree (or higher) in a health profession (i.e. Pharmacy, Medicine)
• At least 2 years of experience in pharmacovigilance and safety department of pharmaceutical companies
• Knowledge and understanding of local and global procedures as applicable.
• Knowledge of legislation with regards to relevant national regulatory guidelines, directives, and regulations in Pharmacovigilance
• Fluency in English language (both verbally and written)
• Interpersonal communication skills
• Attention to detail
• Basic computer skills (MS Outlook, Word, Excel, Power Point)
• Strong knowledge of safety database systems

Pursue progress, discover extraordinary.

Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.

At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity.

Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!

At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.

Pursue progress, discover extraordinary

Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.

At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.

Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!

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