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Lead PV scientist

2.00 to 13.00 Years   Bangalore   26 May, 2021
Merck Ltd
Job LocationBangalore
EducationNot Mentioned
SalaryNot Disclosed
IndustryPharma / Biotech
Functional AreaBio Tech / R&D / Scientist
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 integrated medical safety strategies for the assigned investigational and core (high-risk) marketed products. This includes input into safety aspects of clinical development, risk management and benefit-risk management for assigned products. The PV scientist is responsible for:

  • signal detection and management activities (including evaluation of signals)
  • providing content related safety input into RMPs and periodic safety reports
  • delivering safety related input into and clinical trial documents and activities (i.e. IMPD, IB, Data monitoring Committees, cBR strategy documentation)
  • delivering safety related input into submissions, safety variations
Who you are:CANDIDATE S PROFILEEDUCATIONRequired professional experience and necessary training
  • MD, or PhD/advanced science degree.
  • Fluent in written and spoken English.
WORK EXPERIENCENecessary professional experience
  • MD: Clinical experience (preferably 2 years) and pharmaceutical industry experience (preferably 8 years) or similar (e.g. Health Authority); PhD/advanced science degree: Pharmaceutical industry experience (preferably 10 years) or similar (e.g. Health Authority)
  • Advanced experience in Pharmacovigilance (both in the clinical development as well as the post-marketing area), submission experience
  • Experienced in working in cross-functional, global teams, across different regions.
JOB-SPECIFIC COMPETENCIES & SKILLS Required technical skills
  • Advanced understanding of the end to end drug lifecycle and advanced knowledge of the drug development process
  • In-depth knowledge and demonstrated ability in the application of relevant regulation
  • Advanced knowledge of interpreting individual cases, aggregate safety data & ability to apply statistical principles to safety data
  • Understanding of the current approaches to benefit risk and signal management
  • Demonstrated ability to author safety reports
Required personal skills
  • 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
  • Embraces change and adapts to changing environments
  • Ability to take on responsibilities to further develop her/himself
  • Excellent verbal and written communication skills (in English language)
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!,

Keyskills :
global teamsrisk managementdata monitoringtechnical skillsdrug developmenttherapeutic areasclinical developmentchanging environmentspharmaceutical industryclinical trialgpsmapcbrriskdraw

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