Pharmacovigilance Business Process Writing Lead
Merck
Bangalore, Karnataka, India
6d ago

Your Role :

The Pharmacovigilance Business ProcessWriting Lead will be responsible for the creation of high-quality Pharmacovigilance (PV)-related Quality Documents (QDs) in alignment with the respective Process Owners.

He / she will lead Business Process Management (BPM) strategy and implementation in Global Patient Safety (GPS) ensuring a fit for purpose BPM landscape and respective QDs.

QDs encompass documents such as Policies, Standards, Standard Operating Procedures, and Working Instructions, as well as guidance documents.

For our global PV QDs he / she will ensure content quality, compliance with applicable regulations and Company internal rules and timely availability by applying the BPM methodology.

Key PV processes include but are not limited to areas like Aggregate Reports, Risk Management, Signal Management, Emerging Safety Issues, Urgent Safety Restrictions, Direct Health Care Professional Communication, Safety Communication, Post-Authorization Safety Studies and PV Quality System.

In addition, he / she will ensure that PV requirements are fully implemented in non GPS QDs in adequate quality and compliance with applicable regulations through provision of high-quality reviews including a system and oversight for qualified reviewers / review on behalf of GPS.

Provide leadership for implementation of automated solutions for structured content writing as well as leading implementation of structured content writing for PV Quality Management System related documents, for example the Pharmacovigilance System Master File.

To fulfill the role of the Deputy for the GPS Head of Documentation and Training within the PV System and QPPV function.

Who you are :

  • University degree in natural science, pharmacy or equivalent education with project management experience
  • Strong process orientation and demonstrated professional experience in QD writing
  • Excellent command of MS Office suite
  • 8-10 years of experience from working globally in PV (encompassing the broad scope of PV systems and safety deliverables, including medical safety, and leading cross-functional interactions both within and outside Patient Safety), additional experience in quality assurance is advantageous
  • Fluent professional English required; additional EU languages appreciated
  • Excellent knowledge of GxP quality systems and safety-related regulations (clinical trials and post-marketing, EU and worldwide),
  • Demonstrated practical experience of managing compliance with regulatory standards and requirements
  • Rigorous approach to quality and compliance with attention to detail, personal effectiveness and performance / output driven,
  • Strong intercultural skills (developed from practical experience of international working), strong team-working skills - working across cultural and functional boundaries as well as virtual working experience,
  • Excellent problem-solving ability and negotiation skills,
  • Excellent organizational skills, ability to prioritize work and adapt to changing priorities,
  • Ability to remain calm under pressure and maintaining clear thinking and communication
  • What we offer : With us, there are always opportunities to break new ground. We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons.

    We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life.

    Join us and bring your curiosity to life!

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