Aggregate Report Physician

1 month ago

Bengaluru Karnataka, India ClinChoice Full time

Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it's the best of both worlds.

ClinChoice, is searching for an Aggregate Report Physician to join one of our clients.

**Main Job Tasks and Responsibilities**:

- Aggregate Report Physician should be able to review and contribute to strategy discussions, including determination of the important safety concerns to be included in aggregate.
- Aggregate Report Physician should be able to propose and review the strategy for safety data presentation in Risks, HA feedback topics, signals, and benefit-risk evaluation.
- Coordinate with client's Medical Safety Physicians regarding PBRER steps and hand-offs.
- Review initial draft and final report of complex PBRER and provide feedback to authors.
- Ability to reframe the safety sections during review and make leading changes to the reports in case of any errors/discrepancies/deficiencies observed during the review.
- Electronically approve final PBRER on behalf of MSOs, as required.
- Prepare additional safety reports/documents, such as Ad-hoc safety reports, Benefit-Risk Evaluations, and Risk Management Plans. Ensure the accuracy of the information presented.
- Review medical safety signals and ensure proper disposition and documentation.
- Co-ordinate with QPPVs for their inputs on Aggregate reports, RMP, and Ad-hoc safety reports.

**Education, Experience and Skills**:

- Should have done MBBS with or without MD.
- Minimum 5 years of PV experience and 3 years of exclusive Aggregate Reporting experience including PBRERs.
- Preferred skill - Signal Management and Risk management in addition to aggregate safety reporting.
- Good understanding of ICH E2C (R2) and GVP module 7 guidelines.
- Hands on experience on drafting of PBRER/PSUR for innovator products.
- Excellent written and verbal English communication skills.

**The Application Process**:
**Who will you be working for?**:
**About ClinChoice**:
ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific.

**Our Company Ethos**:
Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel the clear tools needed to manage both internal and client processes with the same methodology. The success of these core values is evidenced by our below industry average turnover rates.

ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it.

**Key words**: Aggregate Report Physician, MD, Medical Doctor, MBS, Pharmacovigilance, PV, GVP, Signal Management, Risk Management, Aggregate Report, PBRER, Clinical Research, CRO, Contract Research Organisation, Outsourced, Outsourcing, Sponsor-dedicated

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