Experienced Pharmacovigilance required, Medical Safety Officer @ iMED Global Corporation, Bangalore, D8

Job description

Under the oversight and delegation from the Medical Safety Officer (MSO) for Monograph Drugs, Devices and Cosmetics, this position develops the strategy and oversees the execution of the pharmacovigilance activities for allocated medicinal, device and cosmetic products and provides recommendation for risk management activities and their execution if necessary.

The MSO owns the post‐marketing safety surveillance plans for allocated products, collaborates with
matrix teams from other client functions and licensing partners on assessment of safety issues and
makes recommendations on actions required to maintain a positive benefit/risk profile of their
products.

The incumbent is responsible for placing safety profile into appropriate scientific and
medical context and be able to present the safety and benefit‐risk profile of the assigned portfolio of
products to key internal and external business partners and health authorities.

The MSO oversees development of safety elements of core labeling, provides medical input into
aggregate reports safety data assessments and ad‐hoc responses to safety questions from regulatory
agencies.

Desired Skills and Experience

Experience in aggregate reports & signal detection

Ability to triage safety information and escalate if appropriate to senior management
Strategy for safety and risk benefit assessment for assigned products.

Recommendations for safety related actions and risk management activities as required.

Represent Office of Consumer Medical Safety on Global Safety Review Group (GSRG),
Labelling Working Group (LWG) and present of safety information to senior management

Review and signatory for safety assessment documents for assigned products.

Interactions with regulatory authorities.

Work planning and assignment within a matrix team

 MBBS / M.D / BDS / M Pharm / Pharm D Required.

4‐5+ years in pharmaceutical, device and/or cosmetic and personal product medicine,
including safety

A sound knowledge of regulatory requirements for pharmacovigilance globally.
Good communication skills, both written and verbal.

About the Company:

MEDGlobal is an innovation driven company providing platforms, services and solutions to global life sciences clients addressing their critical business and scientific needs. Our platforms, services and solutions include Pharmacovigilance, Regulatory Affairs and Clinical Research. Led by a strong management team, with decades of experience and thought leadership with leading pharmaceutical, biotech, medical devices, cosmetic and technology enterprises, iMEDGlobal is designed to deliver high quality and cost effective solutions and services for our clients in the Americas, Europe, Asia and Australia. iMEDGlobal is a preferred partner to major life sciences companies with global presence who have placed their trust in the management, team, infrastructure and capabilities of the company.

At iMEDGlobal we consider our people as the single most important asset.