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Senior PV Scientist

4.00 to 9.00 Years   Bangalore   15 Jun, 2021
Merck Ltd
Job LocationBangalore
EducationNot Mentioned
SalaryNot Disclosed
IndustryPharma / Biotech
Functional AreaSales / BD
EmploymentTypeFull-time

Job Description

A career at our company is an ongoing journey of discovery: our 58,000 people are shaping how the world lives, works and plays through next generation advancements in Healthcare, Life Science and Electronics. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others.United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.Your role: The purpose of this role is to collaborate with the GPS Safety Strategy Leads (SSL) in order to provide medical safety input and ongoing safety surveillance for the assigned marketed products. This includes input into safety aspects of post marketing studies and benefit-risk management for assigned products.The PV scientist is responsible for:

  • providing contributions to safety signal detection and management activities (including evaluation of signals)
  • providing content related safety input into RMPs, periodic safety reports, post marketed study/program related documents and all related safety activities.
The role requires experience with providing the safety input into periodic safety reports and in signal detection and management activities. Any experience in safety contributions to marketing authorization renewal dossiers including addenda to clinical overviews, safety summaries and the RMP, related Health Authority (HA) interactions including responses to HA inquiries would be an asset.Who you are:
  • MD, or PhD/advanced science degree.
MD: Preferably with Clinical experience ; PhD/advanced science degree: Pharmaceutical industry experience (preferably 2 years) or similar (e.g. Health Authority).
  • Basic experience in Pharmacovigilance (both in the clinical development as well as the post-marketing area),
  • Experienced in working in cross-functional, global teams, across different regions.
  • Basic understanding of the end to end drug lifecycle and basic knowledge of the drug development process.
  • Basic knowledge and ability in the application of relevant regulations
  • Basic knowledge of interpreting individual case safety reports, aggregate safety data & ability to understand statistical principles applicable to safety data.
  • Demonstrated ability to author safety reports.
  • Strong team player and excellent networking skills.
  • Solution and results-oriented.
  • Ability to work in intense, fast-paced, multi-national environment, to cope with resistance and solve problems.
  • Demonstrated ability to work under pressure and achieve strict timeline targets, demonstrated ability to lead through complex situations
  • Fluent in written and spoken English.
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!Curious Apply and find more information at https://jobs.vibrantm.com We are committed to promoting a diverse and inclusive workforce. Applications from individuals are encouraged regardless of age, disability, sex, gender reassignment, sexual orientation, pregnancy and maternity, race, religion or belief and marriage and civil partnerships.,

Keyskills :
drug developmentsummarizing informationpharmaceutical industryglobal teamsclinical developmentrmptherapeutic areasgpssignal detectionmappersonal development

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