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PV Publishing Expert

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Sanofi

8d ago

  • Job
    Full-time
    Senior Level
  • Research & Development
    Healthcare
  • Hyderabad, +1

AI generated summary

  • You should have 6+ years in pharmacovigilance, strong global PV knowledge, excellent English, project management skills, and experience with eDMS. A Master's in life sciences is required.
  • You will coordinate and publish PV regulatory submissions, ensure document quality, train staff on eDMS, manage safety report requests, and liaise with stakeholders for compliance and support.

Requirements

  • 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)

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 manage adhoc 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.

FAQs

What is the job title for this position?

The job title is Pharmacovigilance Publishing Expert.

Where is the job located?

The job is located in Hyderabad.

What type of employment is offered for this position?

This position is permanent and full-time.

Is travel required for this role?

Yes, travel is required as per business need.

What are the main responsibilities of the Pharmacovigilance Publishing Expert?

The main responsibilities include overseeing the distribution of Periodic Safety Reports (PSRs), coordinating PV regulatory submissions, ensuring compliance with global publishing standards, and mentoring PV personnel on electronic Document Management Systems (eDMS).

What qualifications are required for this position?

A Master's degree in life sciences or a related field is typically required, along with at least 6+ years of experience in pharmacovigilance or drug safety.

What technical skills are necessary for this role?

Candidates should have experience with electronic Document Management Systems, electronic Report Publishing Systems, advanced knowledge of MS Word, Adobe Acrobat, Excel functions, and a basic understanding of PV/safety databases.

What soft skills are important for the Pharmacovigilance Publishing Expert role?

Important soft skills include stakeholder management, project management, strong communication, strategic thinking, and the ability to work independently and collaboratively within a team.

What language proficiency is required?

Excellent knowledge of the English language, both spoken and written, is required.

Does Sanofi provide equal employment opportunities?

Yes, Sanofi provides equal opportunities to all individuals regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity.

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Sanofi

Science & Healthcare
Industry
10,001+
Employees
2004
Founded Year

Mission & Purpose

We are Sanofi, an innovative global healthcare company. We chase the miracles of science to improve people’s lives. Our team, across some 100 countries, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions.