160626

REGULATORY SCIENTIST at VOISIN CONSULTING LIFE SCIENCES

  • India, Bangalore
  • India
  • India, Bangalore
  • India
Deblocheaza date contact
Traduceri ale CV-ului
40%
  • Ultima actualizare: 13 aug.
  • Numar referinta: 160626

Obiectiv profesional


                            

  • Any, Any, Any
  • Full time
  • Salariul dorit5000 €
  • Domeniile urmariteIt Telecom Project management, Sanatate Sanatate, Sanatate Stomatologie
  • Disponibilitate deplasare in interes de serviciuPana la 25% din program
  • Disponibilitate relocareIn tara si in strainatate

Aptitudini

  • Experienta in management
  • Capacitate de a munci in echipa

Limbi straine

Engleza
Avansat
100%
  • Last update: 13 aug.
  • Reference number: 160626

Career goals

Accomplished, result focused professional with overall 8 years of experience in clinical, Drug safety and Pharmacovigilance with expertise in managing and delivering projects in Pre-marketing and Post- marketing drugs and devices clinical trials. Communicate and coordinate effectively with team members and instill high level of confidence at all levels with a commitment to team success and assignment at hand. Dedicated and fully committed to the highest level of excellence and quality to the ongoing objectives of the organization.

  • Any, Any, Any
  • Full time
  • Salary wanted5000 €
  • Wanted work domainsIt Telecom Project management, Health Health, Health Dentistry
  • Availability for work related travelUp to 25% of the schedule
  • Willing to relocateIn the country and abroad

Experience

  • January 2016 - Present

    REGULATORY SCIENTIST, VOISIN CONSULTING LIFE SCIENCES

    • Bangalore, India
    • Full time
    • Work domain - Health: Pharmacy,Health,Dentistry

    	Spearheading project planning, executing and management.
    	Organizing and providing end to end support for global clinical trials and safety activities.
    	Ensuring adverse events (ICSR’s) are effectively monitored and processed.
    	Ensuring regulatory compliance by submissions of reports within timelines.
    	Budgeting, costing and allocation of resources for the projects.
    	Drafting and finalizing of Safety data exchange agreements (SDEA) and safety management plans for upcoming projects.
    	Supporting EU QPPV, profile creation and maintenance in Eudravigilance for Sponsors. 
    	Ensuring preparation and submission of annual safety reports -DSUR/PSUR.
    	Ensuring the signal detection reports are prepared and submitted before timelines.
    	Coordinating with Vendors and Pharmacovigilance System Master File maintenance (PSMF).
    	Training and mentoring team on project related aspects.
    	Client management and conducting project related meetings.

Education

  • 2003 - 2008

    Doctorate, Rajiv Gandhi university of health sciences

    • Dentistry
    • Bangalore, India

Skills

  • Management experience
  • Communication skills
  • Ability to work in team

	Project Management
	Operations
	Team Management
	Client Management
	Safety Databases (Argus, ArisG)
	ICSR Monitoring & Processing 
	Medical Coding (MedDRA, WHODD)
	Medical Narrative Writing
	Regulatory Reporting
	Signal Detection

THERAPEUTIC AREAS                                           
	Cardiology
	Neurology
	Oncology
	Ophthalmology 
	Rare Diseases
	Medical Devices

Foreign languages

English
Advanced

Achievements

Certificates / diplomas
	Awarded for delivering good quality and excellent performance.
	Appreciated for training and mentoring team members about the process.

Pre-interview

How would you describe your personality?

Young, active, dynamic, professional, team player and a go getter.

What are your goals in life?

I am ambitious and want to go up the ladder and reach high and good position.

Describe your ideal job.

I do not have anything as a ideal  in my mind as long as the role is challenging and have opportunities to grow.

What are the goals set for your career?

I would like to handle more projects and successfully deliver them to client so that I will be prepared to take on more complicated and expanded roles and responsibilities in the future, if and when they become available

Are you able to work effectively in a team or independently?

Yes. I have been both a team player and independent contributor. And I am fine with both the roles.

What job would you like to be doing in 5 years?

I would like to take more challenging roles or high positions in management and also contribute all my skills and expertise for the development of  organisation.

What are/were your most important 5 achievements in your current/past workplace?

	Demonstrated leadership and performed independently in a fast paced environment.
	Delivered to client within deadlines by effectively prioritizing and managing work.
	Headed and executed multiple projects simultaneously and smoothly.
	Directed team and achieved good productivity with excellent Quality.
	Awarded for delivering good quality and excellent performance.
	Appreciated for training and mentoring team members about the process.

What is your monthly salary expectation?

Can be discussed at a later stage as it depends on role and also the location.

Can you work according to deadlines, under pressure, etc?

Yes. The domain which I am in requires to work extremely under pressure and also deadlines are very critical. I enjoy working under pressure and also learnt from my previous experience how to tackle it.