Job Description

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

Qualification :

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