Medical Reviewer

**_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.
- 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, Vari