INDIA - Senior Safety Physician

Location:  Remote - India

This is a remote position intended for candidates based in India, with flexibility for occasional travel based on business needs. Due to system limitations, the role may appear as “United States” on some job platforms—please disregard this; we’re actively seeking talent in India.

The Opportunity

We are seeking a Senior Safety Physician based in India to join our growing Pharmacovigilance team. This is a unique opportunity to ensure compliance with regulatory requirements by providing medical evaluation and oversight of safety data across our clinical development programs.  You will lead Data Safety Monitoring Board (DSMB) coordination across trials while also driving broader pharmacovigilance initiatives, including the analysis, coding, interpretation, and reporting of safety data. The ideal candidate is detail-oriented, decisive, and eager to contribute at both a strategic and operational level.  You will work cross-functionally at the intersection of clinical development, regulatory affairs, and medical safety—contributing directly to the success of our programs and, ultimately, to patients.

Primary Responsibilities

• Coordinate designated Praxis DSMBs, handle all administrative tasks of meeting including scheduling, note taking, logistics, and ensure review and secure filing of all documentation and materials.
• Serve as unblinded pharmacovigilance representative during the closed session of DSMBs, minute the meeting, and communicate all DMSB recommendations to Praxis team.
• Core member of the Pharmacovigilance (PV) team and Safety Review Board
• Support signal detection and safety review activities through data preparation, literature review, and maintenance of safety surveillance plans and risk management strategies.
• Conduct medical review of individual case safety reports (ICSRs), including SAEs, ADRs, and SUSARs.
• Perform aggregate safety data analysis and contribute to safety reports (e.g., DSURs, PSURs/PBRERs, RMPs).
• Support safety-related regulatory submissions and responses (e.g., INDs, NDAs, BLAs).
• Oversee PV vendors to ensure report quality and timely regulatory reporting and ensure timely exchange of safety information; manage PV agreements with business partners.
• Prepare Health Hazard Evaluations and support clinical trial safety monitoring activities, and review of study protocol, informed consent and investigator brochure.
• Communicate safety issues to internal stakeholders and regulatory agencies; represent PV in cross-functional teams.

Qualifications and Key Success Factors

• Medical degree (MBBS or MD) from an accredited institution; postgraduate training (e.g., MD, DNB) is strongly preferred.  May consider highly qualified Nurse Practitioner, PharmD or allied health professional.
• At least 3 - 5 years of relevant experience in a pharmacovigilance role within the pharmaceutical or biotechnology industry; minimum of 1 year of clinical trial experience is highly desirable.
• Experience with regulatory filings and submissions of INDs, NDAs, and MAAs.
• Knowledge of regulatory and compliance requirements governing pharmacovigilance including FDA, EMA, ICH, and GVP.
• Experience in individual case safety reporting (clinical trial and post-marketing), aggregate reporting, signal detection, risk management planning, and regulatory inspections.
• Experience with PV SOP development.
• Experience with implementation of signal detection tools and safety databases is a plus.
• Familiarity with coding using MedDRA and the WHO-Drug dictionary.
• Must possess excellent oral and written English communication skills. 

The physical and mental requirements of our roles include but are not limited to regular use of a computer, devices or other office equipment, clear communication, and occasional movement.  You'll need comfort with screen work, basic hand coordination, and focus.  Reasonable accommodations may be made to enable individuals with disabilities to perform these functions.