INDIA - Senior Safety Physician

Location: This is a remote position based in India, with flexibility for occasional travel as determined by business needs. Note that due to limitations in some internal systems or third-party job platforms, the location may appear as "United States" in certain fields. However, this role is intended to be filled by a candidate located in India.

The Opportunity
We are seeking a Senior Safety Physician to be located in India who will join our growing Pharmacovigilance team. You will be responsible for the medical evaluation and oversight of safety data across clinical development programs, ensuring compliance with regulatory requirements. The ideal candidate will have a strong foundation in pharmacovigilance and clinical safety, and will be responsible for the analysis, coding, interpretation, and reporting of safety data at Praxis. This position offers the opportunity to work at the intersection of clinical development, regulatory affairs, and medical safety, and includes collaboration with cross-functional teams and external partners.

Primary Responsibilities

• Core member of the Pharmacovigilance (PV) team and Safety Review Board; act as unblinded safety representative for DSMBs.
• Coordinate and participate in DSMB meetings, including minute-taking, communication, and safety data support.
• 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.
• Ability to prioritize across complex clinical research studies.
• Demonstrated strategic and critical thinking skills.
• Ability to interact externally and internally to support scientific and business strategies.
• Ability to exercise judgment and address complex problems and find solutions across multiple projects.

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.

Company Overview

Praxis Precision Medicines is a clinical-stage biopharmaceutical company translating genetic insights into the development of therapies for central nervous system disorders characterized by neuronal imbalance. At Praxis we share a common vision of reshaping the human condition into a more freeing and fulfilled existence by developing high impact medicines for patients and families affected by and living with complex brain disorders. Our core Values of Trust, Ownership, Curiosity and Results are foundational to every aspect of our business and are exemplified by each and every one of our team members.

Diversity, Equity & Inclusion
Guided by our core values, at Praxis Precision Medicines, Inc. we continue to DARE FOR MORE to advance, promote, and champion diversity, equity, and inclusion by encouraging individuals to bring their authentic selves and perspectives to work each day. We are an equal opportunity employer and committed to providing opportunities to all qualified applicants without regard to race, religious creed, color, gender identity or expression, age, national origin, sexual orientation, disability, genetics, military service and veteran status, or any other characteristic protected by federal, state, or local laws.

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