Drug Safety Physician / Senior Drug Safety Physician
Location: Remote – Poland, UK, Serbia, Romania, Hungary, Slovakia
Job Type: Regular | Full-Time
Division: Precision for Medicine
Business Unit: Clinical Solutions
Position Summary:
Precision for Medicine is actively hiring a Drug Safety Physician / Senior Drug Safety Physician with line management experience. The role encompasses medical review, oversight of pharmacovigilance activities, signal detection, risk-benefit analysis, and regulatory safety reporting across early and advanced clinical trials. This fully remote role requires strong leadership, regulatory acumen, and collaboration with both internal stakeholders and external CRO teams.
Key Responsibilities:
Pharmacovigilance Oversight:
Manage all Drug Safety and Pharmacovigilance functions.
Lead signal detection, risk communication, and mitigation strategies.
Ensure timely and compliant safety reporting per FDA, EMA, and ICH regulations.
Serve as medical reviewer for SAEs and benefit-risk assessments.
Cross-functional & Regulatory Collaboration:
Collaborate with clinical, regulatory, CROs, and medical writers on safety data assessments and reporting.
Contribute to documents such as protocols, IBs, study reports, ICFs, and responses to IRBs/ethics committees.
Oversee DSMB activities and routine cohort safety reviews.
Systems & Compliance:
Supervise safety data systems and ensure accurate event coding and reconciliation.
Maintain audit and inspection readiness and ensure strong vendor governance.
Contribute to regulatory filings, Risk Management Plans (RMPs), and Pharmacovigilance System Master File (PSMF).
Education & Experience Requirements:
MD degree required.
Minimum 7 years of experience in Drug Safety within pharma/biotech.
Minimum 3 years of oncology safety experience in early-phase trials.
Demonstrated success with regulatory reports and agency inspections.
Proficient in ARGUS safety database and case processing.
Familiarity with hematology/oncology medical terminology.
Skills & Competencies:
Strong working knowledge of FDA, EMA, ICH, and global safety standards.
Excellent verbal and written communication.
Demonstrated leadership and supervisory experience.
Ability to manage multiple priorities in a fast-paced, virtual setting.
High proficiency in MS Office tools and safety platforms.
Demonstrated initiative, accountability, and collaborative mindset.
Travel:
Less than 20% travel expected.
Estimated Salary: €110,000 – €140,000 annually
Gujarat :
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Baddi | Solan |Rajasthan :
Banasthali | Bhiwadi | Jaipur | Pilani | Udaipur |Karnataka :
Bangalore | Belgaum | Bengaluru | B.G Nagara | Bommasandra | Colorado | Czech Republic | Karnataka | Mangaluru | Mysore | Udupi |Punjab :
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Kannur | Kochi | Malappuram | Thiruvananthapuram | Trivandrum |Pondicherry (Puducherry) :
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Siliguri |Illinois :
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Appleton | Kenosha | Pleasant Prairie | Portage | Waukesha |United states :
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Frank Scottile Blvd |Missouri :
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Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
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Istanbul | Turkey |Norway :
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Galway |County Dublin :
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China | Quarry Bay |Liaoning :
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Hangzhou |Tokiyo :
Osaka | Tokyo |Shanghai Sai :
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Wuhan |Capital of Netherland :
Amsterdam |North Brabant :
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Leiden |Netherlands :
Netherlands |Remote Australia :
Arkansas | Remote Australia |New South Wales :
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Queensland |Melbourne :
South Yarra |United Kingdom :
England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |North Yorkshire :
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Sheffield |Oxfordshire :
Witney |Ontario :
Australia | North York | Mississauga | Richmond Hill | Uxbridge | Renfrew |Canada :
Canada |Quebec :
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Brussels |Antwerp :
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Zaventem |South America :
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Athens | Koropi |Greece :
Greece |North Island :
Auckland |New Zealand :
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Madrid |Cebu Province :
Cebu City |Philippines :
Manila |Croatia :
Croatia |Zagreb :
Zagreb |Estonia :
Tartu | Estonia |Harju County (Maakond) :
Tallinn |Hà Nội :
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Ho Chi Minh City |Italy :
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Saitama | Japan |Tokyo :
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Kuala Lumpur |Kyiv Oblast :
Kyiv |Lima Region :
Lima |France :
Lyon | Paris |South Africa :
South Africa | Midrand |Nišava District :
Niš |Bohemia :
Prague |Chile :
Santiago |Bosnia and Herzegovina :
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