1 - 6 Years
Bengaluru

Job Description

We have an opening for '' Safety Surveillance Advisor'' with Pharma MNC .

Location : Bangalore

Qualification : MBBS + MD ( pharmacology ) will be preferred.

Experience : Relevant exp. of 1 to 2 years.

Establishment of the product safety profile
 Develop and update the minimum mandatory safety information (MMSI) for use in the Informed Consent
 Owner of the safety sections of the labelling for the evolving Company Core Data Sheet (CCDS) for developments products
 Maintenance of the labelling for marketed products and member of the Product Labelling Committee (PLC) Review Group
 Perform ongoing and systematic surveillance of all accessible data within allocated product area(s), take initial actions to mitigate risks in case a safety signal or alert is detected or aggravated and document the results of the safety surveillance for the period
 Conduct periodic literature surveillance for marketed products and for development products (if applicable)
 Provide safety input to Product Development Plan (PDP), Trial Outline, Protocol, Clinical Trial Report, Investigator's Brochure (IB), integrated safety summaries, abstracts and planned publications
 Provide proactive safety communication by participation in project/trial groups/teams established, as appropriate and conduct Investigator training as required
 Provide answers to enquiries from HAs and Ethics Committees (ECs) regarding safety aspects of protocols and Patient Information (PI)/ Informed Consent (ICs)
 Establish and ensure deliverables to/from Data Monitoring Committees (DMCs) 
 As author prepare Development Safety Update Reports (DSURs), periodic SUSAR reports, Periodic Safety Update Reports (PSURs) and clinical Risk Management Plans (RMPs) according to implementation plans or as required by HAs

If interested pls send updated CV at rakshat@epharmafocus.com

Salary: INR 8,00,000 - 18,00,000 P.A.

Industry:Pharma / Biotech / Clinical Research

Functional Area:Medical, Healthcare, R&D, Pharmaceuticals, Biotechnology

Role Category:Medical Professional

Role:Chief Medical Officer/Head Medical Services

Employment Type:Permanent Job, Full Time

Keyskills

Desired Candidate Profile

Please refer to the Job description above

Education-

UG:MBBS - Medicine

PG:Medical-MS/MD - Any Specialization

Company Profile

Pharma Focus

We have been retained by MNC pharma company to recruit '' Safety Surveillance advisor'' at Bangalore
View Contact Details+

Recruiter Name:Raksha Toshniwal

Contact Company:Pharma Focus

Reference Id:SSA2201