Local PV Responsible Perú (Temporal)

Position:R2765862 Local PV Responsible Perú (Temporal)

• Location: San Isidro, Lima, Perú

About us

At Sanofi Consumer Healthcare, we have one overarching mission - to work passionately, challenging ourselves and our industry every day, to drive what we believe is the next health revolution: evolving from simply serving consumers, to helping people help themselves - bringing “Health in Your Hands”.

We are building trusted & loved brands that connect with hundreds of millions of consumers worldwide, enabling better self-care for individuals and communities, while also contributing to a healthier planet. To fulfill this mission, we are embarking our consumers, our customers, healthcare professionals, and our employees in this journey because this is what will make us become the “Best Fast Moving Consumer Healthcare (FMCH) Company In & For the World”.

Consumers at the heart of everything we do and we want to make a difference where it counts, driving leadership in the categories we play in: Allergy, Digestive Wellness, Pain, Physical & Mental Wellness, and Cough, Cold & Flu.

To achieve this, we need strong talent who will help us shape the future of our Consumer Healthcare business and challenge our industry. We aspire to create a work environment where people can thrive, grow, and be at their best every day. We believe in operating with integrity and prioritizing the health and well-being of people and communities where we operate, working towards making a positive impact in the world.

About the job

Main responsibilities

• Serves as the local PV contact for the authorities, is accountable for PV inspections and is nominated as local Responsible Person for Pharmacovigilance (RPP/QPPV) for the CHC products where applicable per national regulations. Designate a back-up who replaces him/her when he/she is out of the office

• Is recognized as the key leader for all PV related activities at country level, including but not limited to case management, local safety surveillance, signal detection, risk management and risk mitigation activities, patient support programs market research programs for PV aspects.

• Ensures that local PV activities in the assigned country 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.

• Establishes and maintain robust and efficient local PV systems in the designated country by ensuring the availability and implementation of proper systems/procedures tools and training. Support the QPPV in overseeing the PV activities in the country.

• Support the CHC Head of Safety with regards to local budget planning and maagement.

• 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.

• Act as Deputy CSH for a partner country.

KEY Accountabilities

Local and Global Partnership

Local:

• Represent PV in interactions with local GxP and non GxP functions, to optimize coordination and collaboration in areas of overlapping interests:

• Build and maintain robust collaboration/interaction with the in-country partner functions, to carry out and monitor local PV activities, in compliance with PV regulatory requirements and company procedures/guidelines, and particularly.

• Build and maintain robust working relationship with local external PV vendors as well as Global PV vendors operating local activites.

Global:

• Identify issues or dysfunction in the assigned country(ies) and escalate to senior PV Management,

• In case of local PV outsourcing activities, collaborate with Global PV to implement the best outsourced capabilities

• Interact with Global PV for any questions related to the safety profile of CHC products originating from HA or any other sources.

Organization and maintenance of local PV Quality system

• Establish and implement processes in compliance with regional/local PV regulations and global procedures and cooperate with the local Quality Head to document them in local Quality Documents as appropriate

• Ensure maintenance of local quality documents owned by PV to include documented reviews, gap assessments and revisions as per global requirements.

• Develop and maintain the local PV System Master File for the assigned country as required and in accordance with local regulations and the global standards.

• Ensure that education and training on PV and relevant safety topics within the local organization are performed including documentation of attendees and topics covered (i.e. PV Awareness, training of service providers and manufacturing sites)

• Manage local compliance metrics generation and ensure data capture in the appropriate tools.

• Document PV process non-compliance to include investigation, Root Cause Analysis (RCA), Corrective Actions/Preventive Actions (CAPAs) implementation and coordinate related tracking activities with local Quality Head.

• Warrant audit and inspection readiness of the local PV systems (auditable trail of all PV activities performed in the country is maintained and readily available) with key stakeholders (i.e. Quality, Medical, Regulatory)

• Complete in timely manner audit and inspection observations in close interaction with Global /Local Functions

Organization and Maintenance of PV Operating & Safety Management System

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

• Monitor continuously in-coming communication to ensure the detection and appropriate management of in-coming PV data (ICSRs and other safety related information) to report them in timely manner to Global PV Operations and subsequently to external stakeholders, such as HAs, partners.

• 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 ,

• Ensure screening of local scientific / medical literature and management of relevant abstract/articles

• Ensure appropriate implementation and monitoring of PV requirements for global, regional and local programs (e.g. Patient Support Program, Market Research, Managed Access Program...), and company sponsored digital media

• Ensure screening and analysis of national regulations, and forward any future/new/updated PV regulation as per defined processes

• Secure that for all global/local Business Partner agreements, requiring safety provisions, a local SDEA or PV Clause is set-up, implemented and maintained as appropriate.

• In case of local outsourcing of PV activities to third parties (i.e. vendors/service providers/CROs), Manage contract/work order with local service provider, monitor the appropriate execution of outsourced activities and take the appropriate measures in case of deviations

• Support the Global PV and particularly the QPPV with local safety surveillance activities

• Handle/escalate product safety alerts in timely manner

• 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 the assigned country.

• Ensure that PV unit is involved in reviewing relevant safety sections of local documents, owned by other affiliates entities, such as labeling, contracts with third parties and local study protocols.

About You

Experience:

• At least 1 or more years of pharmacovigilance/clinical development experience.

• Experience with pharmacovigilance systems and safety related product management in both clinical development and marketed products

• Appropriate experience with Regulatory Agency interactions

Soft skills:

• Pragmatic, adaptable, solution oriented mindset; problem-solving, prioritize, take initiative and meet challenges

• Good written and verbal communication skills. Good level of speaking/writing English.

Technical skills:

• Knowledge of national PV regulations and international regulations regarding safety requirements as well as industry standards

Education:

• Bachelor´s degree in Health Sciences like Medicine, Pharmacy, Nursing, odontology, Veterinary or similar.

Languages:

• Local language & English fluent 

Why choose us?

• Bring the miracles of science to life alongside a supportive, future-focused team.

• Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.

• Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.

• Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave.

• Play an instrumental part in creating best practice within our manufacturing facility.

• Our Waterford site is easily accessible from the M9 and offers excellent facilities including a subsidized restaurant and newly refurbished gym.

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