About the role
We are building somethingEPIC.
Evestia Clinical is a biotech-focused global CRO delivering authentic expertise and personalized support where client need it most.
Our foundation is built on four core principles: Innovation drives us to seek new solutions, Excellence defines the high standards we keep, and genuine Care ensures a supportive culture for both our patients and our people. We foster Partnership in everything we do, believing that working together—with trust and flexibility—is the key to success.
Our approach is agile by nature and personalized by design. This translates to a workplace where you are empowered to find the creative solutions necessary for our collective success. We offer a welcoming, flexible, and supportive culture that values trust and belonging, ensuring you have the support needed to grow your skills and thrive while making a difference. We partner with our clients to provide expert knowledge and guidance through complex clinical trials in rare disease, oncology, neurology, immunology, and inflammation. At Evestia Clinical, you will become a vital part of a global specialist CRO. This means you will deliver life changing impact through clinical excellence.
We are committed to creating development opportunities that allow your skills to grow right alongside ours. If you are inspired by this collaborative environment and ready to change the lives of patients worldwide, we’d love to welcome you to our team.
About the Role
We are seeking an experienced Pharmacovigilance Physician to provide medical leadership and expert oversight of safety data across investigational and marketed products. In this role, you will be responsible for the medical review and assessment of Individual Case Safety Reports (ICSRs), proactive signal detection and evaluation, and the review of periodic aggregate safety reports, including PBRERs and PSURs.
You will also work closely with our Medical Affairs team, providing specialist medical input and supporting the clinical medical monitoring team. This position offers the opportunity to contribute across both pharmacovigilance and broader clinical functions, helping to ensure the ongoing safety and benefit-risk assessment of the products we support.
What will your job look like?
Pharmacovigilance & Safety Operations
Perform robust medical review of ICSRs from clinical trials and post-marketing projects, ensuring accurate assessment of seriousness, causality, and expectedness/labeledness.
Review and ensure the medical accuracy and appropriateness of MedDRA and WHO Drug coding for adverse events and concomitant medications.
Author scientifically valid medical assessments, company comments, and concise medical summaries for complex or serious reported events.
Author safety-related queries to investigative sites or reporters to ensure complete and accurate clinical data collection.
Review and contribute to cumulative analyses of similar adverse events to support regulatory reporting and safety evaluations, including Analysis of Similar Events (AOSE) where applicable.
Provide medical support, guidance, mentoring, and training to the PV team, as required.
Review scientific literature to identify potential safety signals or valid ICSRs.
Apply sound medical judgment and clinical expertise to provide advice, data interpretations, and strategic guidance to PV and other internal functional departments, clients, and external partners.
Provide medical input for responses to regulatory authority requests, inspections, and sponsor audits and safety inquiries
Aggregate Reporting & Signal Management
Provide crucial medical input, review, and approval for periodic post-market and clinical safety reports, including PBRERs, PSURs, and DSURs.
Participate in active and routine signal detection activities. Evaluate potential safety signals, review safety data trends, and contribute to signal validation and assessment reports.
Contribute to integrated benefit-risk assessments throughout the product lifecycle and provide medical interpretation of evolving safety profiles.
Participate in or present safety data at internal Safety Management Committees (SMCs) or Data Safety Monitoring Boards (DSMBs) or sponsor safety governance meetings as contracted, providing medical interpretation, clinical context, and recommendations to support informed safety decision-making.
Contribute to the development and maintenance of Risk Management Plans (RMPs) and provide medical input for Safety Management Plans (SMPs).
Provide flexible, occasional support to the clinical medical monitoring function to ensure project continuity during peak workloads or team absences.
When supporting clinical operations, assist in responding to site investigators regarding protocol eligibility, safety concerns, and data management queries.
Perform ad-hoc medical review of clinical trial data listings, laboratory reports, and subject profiles to ensure medical accuracy and identify potential safety concerns.
Quality & Regulatory Compliance
Ensure all pharmacovigilance and medical monitoring activities comply with applicable global regulations (e.g., ICH-GVP, ICH-GCP, FDA, EMA), SOPs, and client requirements
Education:
Primary medical degree (e.g., MD, MBBS, MBChB, DO or equivalent) from an accredited medical school is required.
Active or previously held medical license/registration is required.
Experience:
A minimum of 2 years of experience as a physician in the pharmaceutical industry or a CRO, with a primary focus on Pharmacovigilance and Drug Safety.
Proven, hands-on experience performing medical review of ICSRs.
Experience with aggregate safety report (PBRERs, PSURs, DSURs) review and generation is a plus.
Working knowledge of global regulations regarding drug safety and pharmacovigilance (ICH, FDA, EMA).
Strong scientific, clinical, and analytical knowledge with excellent ability to read, analyze, and interpret scientific data.
Demonstrated ability to analyze and interpret complex scientific and clinical data.
Competencies & Skills
Excellent oral and written communication skills, with the ability to interact effectively with Investigators, clients, and regulatory authorities.
Highly proficient in utilizing electronic applications, specifically the ability to efficiently navigate clinical and pharmacovigilance safety databases to conduct medical reviews and extract data.
Ability to exercise independent medical judgment and make timely, evidence-based decisions in time-sensitive situations, including complex safety assessments, benefit-risk evaluation, signal management, and clinical trial eligibility support when required.
Excellent cross-functional collaboration and communication skills, with the ability to work effectively across multidisciplinary teams and with external stakeholders.
Strong knowledge of MedDRA and WHO Drug coding dictionaries.
What we offer you in return?
We believe that to do your best work, you need the best support. That's why we care deeply about your wellbeing, personal development, and achieving a true work-life balance.
As part of our team, you'll have the opportunity to influence patient safety on a global scale while working with talented colleagues who share a passion for scientific excellence. We offer a collaborative and flexible working environment, opportunities for professional growth, and the chance to contribute to meaningful work that ultimately benefits patients around the world.
Ready to Take the Next Step?
Does joining Evestia Clinical and making a global impact excite you? Then it's time to apply!
We are eager to meet ambitious candidates. Remember, we hire for potential and passion. Therefore if you feel you're a good fit but don't meet every single requirement, please submit your application anyway. We want to hear from you.
Originally posted on Himalayas