Medical Reviewer-Drug Safety
Sitero is an emerging leader in Clinical services and software solutions for the life sciences industry. We have experience and expertise in a diverse range of therapeutic areas and focus on innovative, technology-enabled solutions that allow our clients to focus on their core strengths. For early phase studies through Phase III clinical trials, our experienced team delivers high-touch services and technology to ensure the safety of all stakeholders across the clinical research community with an emphasis on ethics, compliance, and innovation.
Job Title : Medical Reviewer
Location : Mysore-Hybrid
Function : Drug Safety
DESCRIPTION:
Medical Reviewer is the key contact person for assigned clinical development or marketed products, responsible for safety strategy and major safety deliverables, including both early and late-stage development, as assigned. He/she is accountable for safety and risk management activities for one or more assigned products. He/she will manage cross-functional assessment of benefit-risk profile and communication of safety information for assigned product(s). The individual will be an integral part of a group of safety professionals within Sitero and will closely collaborate with safety teams in Contract Research Organizations (CROs) and partners. He/she will need to maintain medical knowledge as required by the role, strong and current knowledge of drug safety and pharmacovigilance regulations, pharmacovigilance practices, safety surveillance and risk-management practices.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
Lead Pharmacovigilance (PV) and risk management activities across all aspects.
Coordinate all post-marketing regulatory reporting and PV activities for assigned products with the Sitero aggregate reporting team.
Assess relevant data for product-specific reports.
Draft and oversee (by separate reviewers) all individual, aggregate, and cumulative medical assessments and benefit-risk evaluations for safety reports.
Provide medical oversight in the drafting of reports following approved Standard Operating Procedures (SOPs) and Work Instructions (WIs).
Coordinate internal review processes and finalize draft reports from a medical perspective.
Assist medical writers in addressing client feedback and finalize reports accordingly.
Review finalized reports, ensuring adherence to quality standards even if involved in earlier drafting stages.
Offer expert guidance in Pharmacovigilance and Aggregate reporting domains.
Contribute significant medical content and insights for Aggregate Safety Reports including PSUR, PBRER, PADER, Summary Bridging Report, Addendum to Clinical Overview, DSUR, RMP, and addendum to PSUR.
Responsible for the medical assessment, recommendations, and conclusions sections of Aggregate Safety Reports.
Prepare and review responses to ad hoc regulatory queries.
Scientifically interpret relevant data for inclusion in drug safety documents, and prepare analytical aggregate reports and other medical documents.
Ensure all documents adhere to SOPs, conventions, and regulatory requirements.
Plan, organize, and manage daily activities to meet service-level timelines and deliverables.
Collaborate with the Sitero Aggregate Reporting team lead to address issues or tasks beyond standard responsibilities.
Serves as a subject matter expert for vendors providing drug safety and pharmacovigilance services.
Training and mentoring of Pharmacovigilance Physicians and Specialists.
Maintain accurate records by documenting report completion and submission dates in the internal tracking log.
Other Responsibilities:
Thoroughly familiarize oneself with and adhere to organizational standard operating procedures (SOPs).
Assist in setting and reinforcing departmental standards.
Collaborating with internal colleagues to swiftly address challenges.
Identifying innovative avenues to enhance organizational and departmental processes.
Supporting team members in achieving their objectives.
Fulfilling any other duties as required.
EDUCATION AND EXPERIENCE REQUIRED:
1-3 years experience in Clinical Practice required. 1+ yr of experience in Drug Safety and Pharmacovigilance in pharmaceutical or biotech company, CRO or regulatory agency within Drug Safety/Pharmacovigilance, with both investigational and marketed products is preferable.
Medical Degree (MBBS or higher) from recognized medical school.
PREFERRED SKILLS:
Good working knowledge of US and EU drug safety regulations, CIOMS and ICH guidelines.
Demonstrated experience with medical drug safety assessments, drug safety surveillance and monitoring activities.
Ability to build relationships, collaborate and influence across disciplines within Sitero and with outside stakeholders.
Excellent verbal, written and presentation skills.
Innovative, collaborative, initiative-taker.
COMPENSATION & BENEFITS:
Sitero proudly offers an impressive compensation package and benefits, including a competitive salary, Variable pay, paid time off, and healthcare and retirement benefits.
EMPLOYMENT TYPE:
Permanent, Full Time
COMMITMENTS:
Standard Hours 40 hours per week, one hour lunch, Monday Friday. Additional hours as needed.
Willing to work in shifts as and when needed.
DISCLAIMER:
Sitero is an equal opportunity employer and welcomes all job applicants. All qualified applicants will receive consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other factors prohibited by law.
