Job Description
Responsibilities
Data Entry and Quality Check of ICSRs in pharmacovigilance database (e.g. ARISg)
Preparation and review of Aggregate Reports (e.g. PSURs/PADERs) as per the Regulations and SOPs
Participate in signal detection activities for ADRs
Generation and review of SOPs and WPGs
Execution of Company Standard Operating Procedures
Management of Compliance with the Company Standard Operating Procedures and regulatory requirements
Liaise effectively and maintain excellent relationship with the clients and internal/external contacts
Maintain awareness of changes to/new regulations affecting Pharmacovigilance activities. Communicate new or changed regulations to management and to relevant members of the department in order to initiate any change in processes
Build and maintain good relationships across functional units and company affiliates
Train and mentor new employees in pharmacovigilance
Carry out necessary administrative duties required for the job
Other duties relevant to this position, as assigned by management
Data Entry and Quality Check of ICSRs in pharmacovigilance database (e.g. ARISg)
Preparation and review of Aggregate Reports (e.g. PSURs/PADERs) as per the Regulations and SOPs
Participate in signal detection activities for ADRs
Generation and review of SOPs and WPGs
Execution of Company Standard Operating Procedures
Management of Compliance with the Company Standard Operating Procedures and regulatory requirements
Liaise effectively and maintain excellent relationship with the clients and internal/external contacts
Maintain awareness of changes to/new regulations affecting Pharmacovigilance activities. Communicate new or changed regulations to management and to relevant members of the department in order to initiate any change in processes
Build and maintain good relationships across functional units and company affiliates
Train and mentor new employees in pharmacovigilance
Carry out necessary administrative duties required for the job
Other duties relevant to this position, as assigned by management
Salary: Not Disclosed by Recruiter
Industry: Pharma / Biotech / Clinical Research
Functional Area: Medical, Healthcare, R&D, Pharmaceuticals, Biotechnology
Role Category: Drug Regulatory Affairs/Documentation
Role: Regulatory Affairs Manager
Keyskills: Senior Pharmacovigilance AssociateICSRsAggregate Reportsliterature searchessignal detectionpharmacovigilance regulatory
Apply Here : http://jobsearch.naukri.com/job-listings-Senior-Pharmacovigilance-Associate-QC--APCER-Pharma-Ahmedabad-1-to-2-years-300913900587?f=300913900587&f=-300913900587Desired Candidate Profile
Education:
UG - B.Pharma - Pharmacy, BDS - Dentistry
PG - M.Pharma - Pharmacy
Doctorate - Doctorate Not Required
PG - M.Pharma - Pharmacy
Doctorate - Doctorate Not Required
Experience: 1.5 yrs 2 yrs
- B.Pharm / M. Pharm / B.D.S. / B.A.M.S./ B.H.M.S. / B.U.M.S
- Experience in various aspects of pharmacovigilance including ICSRs, Aggregate Reports, literature searches, signal detection etc
- Knowledge of pharmacovigilance regulatory requirements will be an added advantage
- Excellent written & spoken English
- Meticulous, with an eye for detail
- Good time management and presentation skills
- B.Pharm / M. Pharm / B.D.S. / B.A.M.S./ B.H.M.S. / B.U.M.S
- Experience in various aspects of pharmacovigilance including ICSRs, Aggregate Reports, literature searches, signal detection etc
- Knowledge of pharmacovigilance regulatory requirements will be an added advantage
- Excellent written & spoken English
- Meticulous, with an eye for detail
- Good time management and presentation skills
Company Profile
APCER Pharma
We are an Indian subsidiary of a fast growing Multinational CRO that provides comprehensive drug safety and regulatory services and risk management programs to pharmaceutical, biotechnology, medical device, and consumer products companies worldwide, using best in class validated technology platforms. Within our global framework, we have built local teams of qualified professionals in different countries to strategically tap the best available resources in order to provide unsurpassed, timely, cost effective, fully integrated and serviced solutions to our customers. Contact Details
Recruiter Name:HR
Contact Company:APCER Pharma
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