Local Pv Responsible Perú (Temporal)

Position : R2765862 Local PV Responsible Perú(Temporal) - Location : San Isidro, Lima, Perú About us At SanofiConsumer Healthcare, we have one overarching mission - to workpassionately, challenging ourselves and our industry every day, todrive what we believe is the next health revolution : evolving fromsimply serving consumers, to helping people help themselves -bringing Health in Your Hands .

We are building trusted brands that connect with hundreds of millions of consumersworldwide, enabling better self-care for individuals andcommunities, while also contributing to a healthier planet.

Tofulfill this mission, we are embarking our consumers, ourcustomers, healthcare professionals,
and our employees in thisjourney because this is what will make us become the Best FastMoving Consumer Healthcare (FMCH) Company In & For the World .

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

To achieve this, we needstrong talent who will help us shape the future of our ConsumerHealthcare business and challenge our industry.

We aspire to createa work environment where people can thrive, grow, and be at theirbest every day. We believe in operating with integrity andprioritizing the health and well-being of people and communitieswhere we operate, working towards making a positive impact in theworld.

About the job Main responsibilities - Serves as the local PVcontact for the authorities, is accountable for PV inspections andis nominated as local Responsible Person for Pharmacovigilance(RPP / QPPV) for the CHC products where applicable per nationalregulations.


Designate a back-up who replaces him / her when he / sheis out of the office - Is recognized as the key leader for all PVrelated activities at country level, including but not limited tocase management, local safety surveillance, signal detection, riskmanagement and risk mitigation activities, patient support programsmarket research programs for PV aspects.

- Ensures that local PVactivities in the assigned country are performed in compliance withthe Global PV policies, as well as global, regional and local PVregulations to warrant safe and appropriate use of CHC products onthe market in the assigned country.
- Establishes and maintainrobust and efficient local PV systems in the designated country byensuring the availability and implementation of propersystems / procedures tools and training.

Support the QPPV inoverseeing the PV activities in the country.
- Support the CHC Headof Safety with regards to local budget planning and maagement.

- Builds close and robust relations / collaboration with the in-countrypartner functions, including but not limited to Medical,Regulatory, Quality, Commercial, Legal, and Country Manager.
- Actas Deputy CSH for a partner country. KEY Accountabilities Local andGlobal Partnership Local : - Represent PV in interactions with localGx P and non Gx P functions, to optimize coordination andcollaboration in areas of overlapping interests : - Build andmaintain robust collaboration / interaction with the in-countrypartner functions, to carry out and monitor local PV activities, incompliance with PV regulatory requirements and companyprocedures / guidelines, and particularly.
- Build and maintainrobust working relationship with local external PV vendors as wellas Global PV vendors operating local activites.


Global : - Identifyissues or dysfunction in the assigned country(ies) and escalate tosenior PV Management, - In case of local PV outsourcing activities,collaborate with Global PV to implement the best outsourcedcapabilities - Interact with Global PV for any questions related tothe safety profile of CHC products originating from HA or any othersources.

Organization and maintenance of local PV Quality system -Establish and implement processes in compliance with regional / localPV regulations and global procedures and cooperate with the localQuality Head to document them in local Quality Documents asappropriate - Ensure maintenance of local quality documents ownedby PV to include documented reviews, gap assessments and revisionsas per global requirements.


- Develop and maintain the local PVSystem Master File for the assigned country as required and inaccordance with local regulations and the global standards.
- Ensure that education and training on PV and relevant safety topicswithin the local organization are performed including documentationof attendees and topics covered (i.

e. PV Awareness, training ofservice providers and manufacturing sites) - Manage localcompliance metrics generation and ensure data capture in theappropriate tools.

- Document PV process non-compliance to includeinvestigation, Root Cause Analysis (RCA), CorrectiveActions / Preventive Actions (CAPAs) implementation and coordinaterelated tracking activities with local Quality Head.
- Warrantaudit and inspection readiness of the local PV systems (auditabletrail of all PV activities performed in the country is maintainedand readily available) with key stakeholders (i.

e. Quality,Medical,
Regulatory) - Complete in timely manner audit andinspection observations in close interaction with Global / LocalFunctions Organization and Maintenance of PV Operating & SafetyManagement System In compliance with PV regulatory requirements andcompany procedures / guidelines, - Monitor continuously in-comingcommunication to ensure the detection and appropriate management ofin-coming PV data (ICSRs and other safety related information) toreport them in timely manner to Global PV Operations andsubsequently to external stakeholders, such as HAs, partners.

Handle appropriately local periodic reports, including periodicsafety reports (PSRs) and periodic reviews, and contribute togetherwith Global PV, Clinical Operations and RA departments to theplanning for PSRs ,
- Ensure screening of local scientific / medical literature and management of relevant abstract / articles -Ensure appropriate implementation and monitoring of PV requirementsfor global, regional and local programs (e.

g. Patient SupportProgram, Market Research, Managed Access Program...), and companysponsored digital media - Ensure screening and analysis of nationalregulations, and forward any future / new / updated PV regulation asper defined processes - Secure that for all global / local BusinessPartner agreements, requiring safety provisions, a local SDEA or PVClause is set-up, implemented and maintained as appropriate.

Incase of local outsourcing of PV activities to third parties (i.e.vendors / service providers / CROs), Manage contract / work order withlocal service provider,
monitor the appropriate execution ofoutsourced activities and take the appropriate measures in case ofdeviations - Support the Global PV and particularly the QPPV withlocal safety surveillance activities - Handle / escalate productsafety alerts in timely manner - Contribute to the development oflocal RMP, when applicable, with the support and validation of theRisk Management Expert.

Track the actual implementation ofadditional Risk Minimization Measures (a RMMs) in the assignedcountry. - Ensure that PV unit is involved in reviewing relevantsafety sections of local documents, owned by other affiliatesentities, such as labeling, contracts with third parties and localstudy protocols.

About You Experience : - At least 1 or more yearsof pharmacovigilance / clinical development experience. - Experiencewith pharmacovigilance systems and safety related productmanagement in both clinical development and marketed products -Appropriate experience with Regulatory Agency interactions Softskills : - Pragmatic, adaptable, solution oriented mindset;

problem-solving, prioritize, take initiative and meet challenges -Good written and verbal communication skills. Good level ofspeaking / writing English.

Technical skills : - Knowledge of nationalPV regulations and international regulations regarding safetyrequirements as well as industry standards Education : - Bachelor sdegree in Health Sciences like Medicine, Pharmacy, Nursing,odontology, Veterinary or similar.

Languages : - Local language& English fluent Why choose us? - Bring the miracles of scienceto life alongside a supportive, future-focused team.

- Discoverendless opportunities to grow your talent and drive your career,whether it's through a promotion or lateral move, at home orinternationally.
- Enjoy a thoughtful, well-crafted rewards packagethat recognizes your contribution and amplifies your impact. - Takegood care of yourself and your family, with a wide range of healthand wellbeing benefits including high-quality healthcare,prevention and wellness programs and at least 14 weeks'gender-neutral parental leave.
- Play an instrumental part increating best practice within our manufacturing facility. - OurWaterford site is easily accessible from the M9 and offersexcellent facilities including a subsidized restaurant and newlyrefurbished gym.

Pursue progress. Discover extraordinary. Better isout there. Better medications, better outcomes, better science. Butprogress doesn't happen without people people from differentbackgrounds, in different locations, doing different roles, allunited by one thing : a desire to make miracles happen.

So, let's bethose people. At Sanofi, we provide equal opportunities to allregardless of race, colour, ancestry, religion, sex, nationalorigin, sexual orientation, age, citizenship, marital status,disability, or gender identity.

Watch our ALL IN video and checkout our Diversity Equity and Inclusion actions atsanofi.com