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INDIA - Senior Safety Physician

India - Remote

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.

Annualized Base Salary

₹3,485,000 - ₹4,200,000 INR

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.

Attention: Job Scam Alert
Praxis has recently become aware of fraudulent job recruitment postings from individuals claiming to represent Praxis. These postings seek financial information in connection with fraudulent opportunities for employment. If you suspect any fraudulent activity or misrepresentation in connection with a Praxis job opportunity, please report it to careers@praxismedicines.com.

Praxis does not accept unsolicited submissions from recruitment agencies for open positions. We ask all recruitment agencies to refrain from contacting any Praxis employee regarding any position. All unsolicited resumes submitted by recruitment agencies to any Praxis employee in any form or method will be deemed to be the property of Praxis, and Praxis explicitly reserves the right to hire those candidate(s) without any financial obligation to the recruitment agency.

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I hereby authorize Praxis Precision Medicines, Inc. (the "Company") or any designated officer, employee, agent, or representative to confer with the references that I have provided consent to contact. I understand that the Company may ask my references questions about my educational background, work experience, achievements, performance, attendance, and reason for separation from former employment, among other things. I expressly authorize my references to answer such questions.

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I certify that all information I have provided in order to apply for and secure work for this Company is true, complete, and correct. All information and documents previously provided to the Company in connection with my application for employment are incorporated by reference herein. I further agree that any information and documents provided to the Company will be true, complete, and correct.

I understand it is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

I understand that any information provided by me that is found to be false, incomplete or incorrect in any respect will be sufficient to (i) constitute sufficient grounds to reject my application for employment without further consideration, or (ii) constitute sufficient grounds to discharge me from employment, whenever it is discovered.

By submitting my application, I expressly authorize, without reservation, the Company, its representatives, employees or agents to contact and obtain information from all references (personal and professional), employers, publishing agencies, licensing authorities and educational institutions and to otherwise verify the accuracy of all information provided by me, including but not limited to information in this application, in my resume, or during a job interview.  I understand Praxis will not contact my current employer without consent prior to acceptance of an offer of employment. I hereby waive any and all rights and claims I may have regarding against the Company, its agents, employees or representatives for seeking, gathering, verifying and/or using such information in the employment process.

I understand that this application remains current for thirty (30) days. At the conclusion of that time, if I have not heard from the Company and still wish to be considered for employment, it will be necessary to reapply and fill out a new application. If I am hired, I understand that I am an at-will employee who is free to resign at any time, with or without cause or notice, and that the Company reserves the same right to terminate my employment at any time, with or without cause or notice, in accordance with applicable law. I understand that if I choose to voluntarily terminate my employment, the Company may either permit me to continue my employment during the notice period or accept my resignation immediately. This application does not constitute an agreement or contract for employment for any specified period or definite duration. I understand that no supervisor or representative of this Company is authorized to make any assurances to the contrary and that no implied, oral or written agreements providing any specified period or definite duration of employment are valid unless they are in writing and signed by the Company’s president.

In the event I am hired, I agree to comply with all rules, policies, and procedures set forth in the Company's corporate policies, employee handbook or other such communications distributed to all employees.

I also understand that if I am hired I will be required to provide proof of my identity and legal authority to work in the United States and that federal immigration laws require me to complete an I-9 Form in this regard.

 

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