Experience

PAREXEL INTERNATIONAL SERVICES INDIA PRIVATE LIMITED

• India
• 1 - 100 Employee

• Medical writer II

  • Mar 2018 - Present

  •Providing input into periodic reports (PSUR, BR, DSUR, ACO, SASR, PADERs, SASRs, checking of INNs for inclusion in a PSR in accordance with client requirements/conventions and SOPs•Performs quality check of PSRs•Ensuring compliance with applicable regulations or standard operating procedures.•Recording and reporting adverse reactions received from healthcare professionals and consumers•The role includes serving link between the company, healthcare experts and patients for delivery of valid information on product safety•Conducting and supervising regular PV processes; attending several product safety meetings and adding functionality to product safety•Responsible for monitoring of all products and conducts postmarket evaluations to ensure drug safety. Involved in assessing adverse event, updating reports on safety, conducting quality and conveying drug related case reports to appropriate authorities•Responsible for GPV activities to support data safety; perform document archiving; assist in the administration of PV meetings; support quality of review documents and initiate business liaison. •Responsible for maintaining liaison with relevant client personnel for obtaining contributions for different sections of the PSR•Other essential duties include drafting PV agendas; accurately archiving PV documents; reviewing safety case data and other PV documents for completeness and accuracy; assisting with tracking, submitting and distributing of periodic reports; assisting liaisons with the partners and cross-functional team members to ensure compliance; supporting various ad-hoc deliverables or PV reports•Perform literature searches and identify/analyze relevant publications•Experienced in international drug safety regulations including ICH guidelines, GVP guidelines, FDA guidelines and CIOMS• Maintaining an awareness of global regulatory obligations and organizing workload to ensure compliance with internal and regulatory timelines experienced in MedDRA coding Show less

• Medical writer II

  • Mar 2018 - Present

  Medical Writer II, Parexel International, Chandigarh, IndiaApril 2022 - PresentMedical Writer I, Parexel International, Chandigarh, IndiaApril 2021 - March 2022Associate Medical Writer, Parexel International, Chandigarh, IndiaJuly 2020 - March 2021Pharmacovigilance Scientist, Parexel International, Chandigarh, IndiaMarch 2018 - June 2020Date of joining: 12-Mar-2018