Assistant Manager Pharmacovigilance

Department

Pharmacovigilance and Clinical Research

Job Description

  • Responsible for creating and enhancing Pharmacovigilance awareness and implementing PV system
  • Responsible for timely submissions of drug safety documents e.g. RMP, PSUR as per country requirements.
  • Ensure quality of safety reporting and timely transfer to Health Authorities
  • Maintain PV database & safety processes through proper archiving of drug safety reporting & queries
  • Develop and maintain the new or revise SOPs related to Pharmacovigilance
  • Develop RMP & PSUR reports along with PV team and ensure timely submissions in relevant regulatory authorities.

Education

MBBS / BDS / Pharm-D

Experience

4 – 5 years working experience in a pharmaceutical or research institute or contract research organizations with focus of Pharmacovigilance & Clinical Research.

Skills

  • Understanding of Pharmacovigilance system specially in context of Pharmaceutical environments
  • Knowledge of ICH guidelines and local regulations
  • Knowledge of the role of medical affairs.
  • Knowledge of scientific methods applied to clinical research.
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Assistant Manager Medical Affairs

Department

Pharmacovigilance and Clinical Research

Job Description

  • Planning and hands-on management of tasks related to medico-marketing initiatives
  • Planning and coordinating for academic and research projects which are in alignment with medical & marketing strategy.
  • Providing scientific and academic support to local & international marketing department and to promote the culture of ethical activities
  • Providing support to PG Trainee doctors in their synopsis or dissertation or manuscript through critical review as per ICH-GCP and local guidelines
  • Planning of capacity building workshops (SIGMA) for productive and sustainable relationships with doctors to across Pakistan
  • Preparation of new SOPs & revisions of SOPs where needed.

Education

MBBS / BDS / Pharm-D

Experience

4 – 5 years working experience in a pharmaceutical or research institute or clinical research environment.

Skills

  • Technical knowledge of Medical Affairs & Research Methodology
  • Understanding of ICH-GCP guidelines
  • Sound knowledge of the pharmaceutical environment and the role of medical affairs
  • Broad understanding of Regulatory Affairs and knowledge of scientific methods applied to clinical research
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