Senior Manager - 2

Location

Mumbai | India

Job description

• This position will involve supporting the Head of clinical safety management for all clinical trials of SPIL, SUN FZE and SPARC

• Responsibilities include review of safety sections of study documents like protocol, IB, CSR and ICF, develop safety management plan for all studies, , participate in dose escalation decisions in early phase studies, ensure regulatory reporting of reportable (SUSAR) cases within the regulatory timeframe,
• Preparation and/or Review of Annual safety update report / DSUR and safety section of IB, ongoing review of safety data for timely detection of any new safety signal or safety trends, Maintain systems and processes to a high standard of clinical safety management

Key responsibilities of the role:

• Review of safety sections of clinical study documents like protocol, CRF, IB, CSR and ICF
• Database all SAEs in safety database for ongoing and future studies.
• Triage, processing, assessment and regulatory reporting of SUSARs and other reportable events to the regulatory agencies
• Review of safety data and participation in dose escalation decisions in early phase studies
• Review SAE reconciliation plan.
• Ongoing review of safety data for timely detection of any new safety signal or safety trends
• Preparation and/or Review of Annual safety update report / DSUR
• Review of clinical trial related safety exchange agreements in line with regulatory requirements and internal company SOPs.
• Make presentation w.r.t safety reporting for IM or site initiation visit (SIV) as required.

Educational Qualification

MBBS

Work Experience:

5 to 6 years

Skills required:

Good Medical writing skills

Understanding of principles of ICSR case management and assessment

Understanding of Good Pharmacovigilance Practices and the several ICH, EMA and FDA guidelines on drug safety and Pharmacovigilance

Job tags

Salary