APCER Life Sciences Hiring Pharmacovigilance Associate

APCER Life Sciences Hiring Pharmacovigilance Associate

20 May, 2022

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


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