Skip Navigation Skip to content

Current Openings - Clinical Department

Pharma


Functional Area : Pharmacovigilance and Clinical Affairs Department

Position Title : Executive / Sr.Executive / Assistant Manger

Education Qualification : M. Pharmacy Pharmacology / Pharm D

Experience : 2 - 5 Years experience.

Job Description

Candidate with good academic background will be considered.

  • Profound knowledge of regulatory guidelines.
  • Able to travel frequently for monitoring the clinical studies executed in different CRO’s.
  • Knowledge on Management of Clinical Trial sites.
  • Knowledge on BE-NOC and Import- License applications for the conduction of clinical studies.
  • Experience in Medical writing activities viz clinical study protocols, clinical study reports (Module 5 eCTD), Non-clinical and Clinical overviews (module 2.4 & 2.5).

Interview Venue : Hyderabad



Pharma / Biotech / Clinical Research


Functional Area : Clinical Affairs and Pharmacovigilance

Role : Medical Writing

Position Title : Trainee / Sr Executive / AM / DM

Education Qualification : M.B.B.S / B.D.S / MD Pharmacology / Pharm D / M. Pharm Pharmacology

Experience : M.B.B.S / B.D.S/ MD Pharmacology (0 - 02 years),
                    Pharm D / M. Pharm Pharmacology (2-8 years)

Job Description

Candidate with good academic background will be considered. Company is Looking for a candidate who can accommodate preferably in Hyderbad location.

Essential function

The Clinical Affairs associate who independently researches, writes, and reviews pre-clinical synopses, clinical study reports, study protocols and standard response documents.

Key Accountabilities

Provides high-quality medical and scientific writing from planning and coordination of literature search through delivery of final drafts. Provides technical consultation and provides substantive advice on strategy, regulations and industry best practices. Demonstrates subject matter and therapeutic area expertise.

Principal Duties and Responsibilities:

  • Produces complex clinical or scientific documents, such as Scientific conclusion, IBs and sections of dossiers.
  • Provides writing support during pre-clinical, clinical and Post-Authorization phases of product development.
  • Providing medical writing support at a clinical trial level.
  • Authors clinical documents following defined templates.
  • Preparation of clinical abstracts and review conclusions during preclinical and clinical development phase of products
  • Actively participates in all planning, coordination and review meetings.
  • Ability to work on multiple assignments simultaneously.

Pharma


Functional Area : Pharmacovigilance and Clinical Affairs Department

Position Title : Executive / Assistant Manger

Education Qualification : M. Pharmacy (pharmacology) / Doctor of Pharmacy /M.B.Bs / B.D.S / MD Pharmacology

Experience : 1 - 5 Years experience.

Job Description

Candidate with good academic background will be considered.

Essential function : The Drug Safety Associate will provide technical and process-related support to drug safety management (post-marketed) and medical monitoring activities, ensuring compliance with relevant regulations and Standard Operating Procedures (SOPs).

Key Accountabilities

  • Preparation/ Review of Periodic Safety Update Reports (PSUR)/ Periodic Benefit Risk Evaluation Report (PBRER)
  • Preparation/ review of Periodic Adverse Drug Experience Reports (PADER)
  • Preparation/ Review of Risk Management Plan
  • Maintenance of Signal Detection Calendar and Signal(s) Management Process
  • Supporting to compliance activities
  • Handling of Regulatory Approvals and Licencing information
  • Weekly scientific literature monitoring in Literature Database
  • Medical Literature Monitoring in EudraVigilance Database
  • Daily Monitoring of EudraVigilance ICSRs
  • Handling of Individual Case Safety Reports (ICSRs)
  • Safety monitoring from regulatory authority websites and regulatory communications

Interview Venue : Hyderabad


Apply Online

*Candidate can apply once for single location

hit counter