Job title: Pharmacovigilance Publishing Expert
Location: Hyderabad
% of travel expected: Travel required as per business need
Job type: Permanent and Full time
About the job
Our Team:
At Sanofi Consumer Healthcare, we have one overarching mission - to work passionately, challenging ourselves and our industry every day, to build a healthier future by helping people, help themselves, bringing “Health in Your Hands”. Our teams 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 fulfil 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”. We strive to act as a force for good by integrating sustainability along our business and employees’ mission and operate responsibly from both a social and environmental point of view. To achieve this, we need strong talent who will help us shape the future of our Consumer Healthcare business and challenge our industry. At Sanofi Consumer Healthcare, we aspire to create a work environment where people can thrive, grow, and be at their best every day. Our priority is working with integrity to improve the health and well-being of people and communities where we operate, working towards making a positive impact in the world. Our Team: The Global Regulatory Strategy & Science Partner Markets Team is a diverse and inclusive team striving to Build a culture of excellence by: Driving operational effectiveness for regulatory processes Enabling strategic decision making on global regulatory strategy portfolio Bridging regulatory portfolio activities with brand needs Monitoring regulatory performance and budget Ensuring operational excellence and ensuring continuous improvement in Partner Markets (G2) for Science Creating value through a best in class CoE structure, processes and talented resources The CHC Science Center of Excellence (CoE) is an internal resource organization based in India and is set-up to centralize processes and activities to run and support Science Customer functions. The CoE strives to be a partner for strategic and tactical deliveries for CHC Science globally to sustain world-class performance and value.
Main responsibilities:
Position Overview:
Within the CHC – Consumer Safety organization, under the direction of the Global Science CoE Lead, the Pharmacovigilance (PV) Publishing Expert will be responsible for distribution of Periodic Safety Reports (PSRs) and will be the process owner for PV Publishing activity in the Company, accountable for distribution of PV reports to countries.
PV Publishing Expert is responsible for providing the strategic vision, planning and oversight on publishing of all CHC PV regulatory documents. This position maintains oversight and responsibility for global publishing vendors.
Key Responsibilities:
Responsible for electronic compliant published reports for submission to regulatory agencies and ensure smooth functioning of electronic document management system (eDMS) and publishing systems.
Responsible for coordination, publishing, and tracking of PV Regulatory submissions. Accountable for submissions packages to be delivered in a timely manner.
Responsible for delivering on-time published reports in required format and ensure high quality standards of documents by providing necessary quality checks.
To improve and reinforce standards, procedures and systems in line with changes in the regulatory environment and best industry practices.
To train, mentor, provide user support to PV personnel/collaborators in the use of eDMS and advanced features of MS (Microsoft) Word.
Responsible to manageadhoc safety report requests.
Liaise with RMP (Risk Management Plan) unit and regulatory unit to ensure the required templates and data are uploaded into eDMS and published.
Provide training and mentoring support to vendor personnel on document management and report publishing activities for PSRs and adhoc safety reports.
Provide input and feedback on PSR authoring, formatting, and submission readiness at vendor oversight meetings.
Provide Veeva Vault and publishing support for GPV Regulatory Response Documents, and other adhoc safety reports for submission. Support the review, approval and notification process of reports published in Veeva Vault.
Ensure successful publishing and submission of Global PSMF in collaboration with QPPV Coordinators.
Act as subject matter expert for the enhancement or implementation of new eDMS and Publishing tools, quality documents, on template management activities.
Lead PV special projects related to publishing and document management.
Liaise with PSR stakeholders to ensure tasks and deliverables meet Regulatory requirements and are in accordance with the QDs.
This role will be the key contact point for countries and regions for all topics related to PSR distributions.
This position requires multiple interfaces with partners and customers within and outside of the Company this includes Regulatory, digital and PV.
Work closely with CHC PSR team members.
About you
Experience: Experience in consumer healthcare, pharmaceuticals, or related industries, ideally 6+ years in pharmacovigilance or drug safety. It requires experience in managing complex issues in a global environment. Strong knowledge of global PV regulations and guidelines (e.g., FDA, EMA, ICH). Proven track record of mentoring a team of PV professionals.
Soft skills: Stakeholder management, project management, communication and interpersonal skills, strategic thinking and ability to work independently and within a team environment. Strong analytical and problem-solving skills. Ability to work collaboratively in a cross-functional team environment.
Technical skills: Experience with electronic Document Management Systems and electronic Report Publishing Systems. Advanced working knowledge of MSWord Templates, Adobe Acrobat, and Excel functions. Technical expertise to determine best practice solutions for eDMS system activities and change controls. Develop training material and perform eDMS training for users across the PV Organization. Basic knowledge of PV/safety database and Sales generation software (MARCO). Knowledge of submission-related activities in accordance with Regulatory guidelines. Ability to write/update/contribute to quality documents/job aids/WINs and developing training material to perform training to PV. Ability to manage and lead transversal meetings and small to moderate size groups and take appropriate decisions.
Education: Master's degree in life sciences or a related field is typically required. Relevant fields include, but are not limited to: Pharmacy, Medicine (Allopathic Medicine only – no alternative medicine), Biochemistry, Biophysics, Microbiology, Biotechnology.
Languages: Excellent knowledge of English language (spoken and written)
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!
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!