Apcer Life Sciences Job Opening For Pharmacovigilance Associate

Apcer Life Sciences Job Opening For Pharmacovigilance Associate

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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