20 May, 2022
Rewarding career opportunity with one of the fastest growing organization, APCER Life Sciences.
- Data Entry of ICSRs in APCER (ArisG, Argus etc.)/client’s pharmacovigilance database duplicate check, entering source data in the database, MedDRA coding, narrative(s) writing, labelling of events, report scheduling (if applicable) & attachment of source document in database
- Screening, evaluation and review of literature articles for identification of valid/potential ICSRs for processing
- Receipt and evaluation of safety data exchange agreements (If applicable) for sharing and other obligations
- Execution of organization’s standard operating procedures
- Management of compliance with the organization’s standard operating procedures and regulatory requirements
- Liaise effectively and maintain excellent relationship with the internal contacts
- Maintain awareness of changes to/new regulations affecting pharmacovigilance activities
- Communicate new or changed regulations to relevant members of the department in order to initiate any change in processes
- Builds and maintains good relationships across functional units and company affiliates
- Escalate critical calls to concerned managers/clients Remain up-to-date with the latest information on the assigned product(s)
- To carry out necessary administrative duties required for the job
- Other duties as assigned by management
- Trains and mentors new employees in PVG (if required)
- Generation and review of SOPs and WIs (if required)
- Complies with applicable ISMS related procedures & policies
- Self motivated
- Good competence with therapeutic and medical terminology
- Meticulous attention to detail client focused approach
- Ability to follow instruction and deliver assigned tasks within agreed timelines
- Aptitude to learn new skills and enhance pharmacovigilance knowledge
- Knowledge of European and ROW (if applicable) regulatory requirements
- Good time and management skills
- Strong interpersonal & communication skills
- Basic knowledge of Microsoft Office/Applicable software
A graduate/post graduate degree in Pharmaceutical sciences/Life Sciences
Submit your CV today to be considered for role within our organization.
Industry : Pharmaceutical & Life Sciences
Functional Area : Research & Development
Role : Medical Writer
Keyskills : Literature, Arisg, MedDRA, drug safety, Individual case study report, Triage, ICSR, Pharmacovigilance, Data Entry, Argus, Duplicate searchEducation Qualification
UG : BHMS in Any Specialization, BAMS in Any Specialization, B.Pharma in Pharmacy, B.Sc in Any Specialization, BDS in Dentistry
PG : MS/M.Sc(Science) in Any Specialization, M.Pharma in Pharmacy, MDS in Any Specialization
Doctorate : Doctorate Not Required
Apply through this Link
I am interested, I need job
I am interested for Pharmacovigilance. I am a fresher.
I am interested doing job in APCER LIFE SCIENCES.
Please Consider me.