Job Description
Pharmacovigilance Associate
Experience & Location: 1-3 yrs. Ahmedabad,
Qualification :
A graduate/post graduate degree in Pharmaceutical sciences/Life Sciences
Rewarding career opportunity with one of the fastest growing organization, APCER Life Sciences.
Job Description:
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
Key Competencies:
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
Key Skills:
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
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