Global Safety Lead Oncology (all genders)
Job Id: 284289
Location: Darmstadt, Hessen, Germany
Job Type: Full-time, part-time possible
About the Role
As the Global Safety Lead Oncology, you will work closely with the Global Program Safety Lead (GPSL) to provide integrated medical safety strategies for assigned development programs or marketed products. You will oversee the effective delivery of pharmacovigilance outputs, including proactive safety surveillance, signal activities, and benefit-risk management. This role involves strategic direction, medical review, safety evaluations, and ensuring regulatory compliance throughout the product lifecycle.
Key Responsibilities
Set the medical safety strategic direction and provide strong and visible safety scientific leadership.
Oversee emerging safety profiles, including medical review of individual case safety reports, signal detection & evaluation, periodic safety reports, and risk-benefit evaluation.
Contribute to the Pharmacovigilance Advisory Board and other R&D governance bodies.
Represent GPS on cross-functional teams and at submission teams, providing safety strategic input into submission documents.
Chair cross-functional safety teams and represent GPS at monitoring committees (e.g., SMC/IDMC).
Prepare for and attend regulatory authority meetings, interacting with external advisers or opinion leaders.
Act as a subject-matter expert on medical safety in discussions with regulatory authorities.
Ensure effective communication of product-related aspects during audits and regulatory authority inspections.
Provide medical safety expertise for due diligence activities, if required.
Qualifications
Education: Physician with clinical experience preferred.
Experience:
Several years of medical experience in Oncology/Haematology preferred.
Minimum of 5 years broad industry experience, including clinical development and pharmacovigilance.
Excellent knowledge of pharmacovigilance regulations and product development processes.
Experience with NDA/BLA or equivalent regulatory submissions or reviews is preferential.
Expertise in safety issues related to known target organ toxicities (e.g., hepatic, renal, hematological).
Expert knowledge of aggregate data analytics, predictive modelling, epidemiology, health outcomes, and biostatistics.
Skills:
Strong decision-making, negotiation, and influencing skills.
Excellent verbal and written communication in English.
What We Offer
We celebrate diversity and believe it drives excellence and innovation. Our inclusive culture encourages personal growth, offering opportunities to develop at your own pace. Join us in building a culture of inclusion and belonging that empowers everyone to work their magic and champion human progress.
Apply now and become a part of our diverse team!
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Bilaspur | Eot Municipality | Raipur |Delhi :
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Ranchi |Karnataka :
B.G Nagara | Bangalore | Belgaum | Bengaluru | Bommasandra | Mangaluru | Mysore | Udupi |Kerala :
Kannur | Kochi | Malappuram | Thiruvananthapuram | Trivandrum |Madhya Pradesh :
Bhopal | Dewas | Gwalior | Indore | Khandwa | Khargone | Pithampur | Ujjain |Maharashtra :
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Panjab :
Pondicherry (Puducherry) :
Pondicherry (Puducherry) |Punjab :
Bathinda | Bela | Chandigarh | Moga | Mohali | Patiala | Phagwara | Rajpura |Rajasthan :
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Birmingham |Alaska :
Anchorage | Barrow | Bethel | Juneau | Sitka | Wrangell |Albama :
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Boulder | Denver | Westminster |Connecticut :
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Wilmington |Florida :
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Hilo | Honolulu |Idaho :
Boise |Illinois :
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Garden city | Kansas City | Lawrence | McPherson |Kentucky :
Edgewood | Ft MItchell | Louisville | Shelbyville |Kington :
Frank Scottile Blvd |LA :
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Bangor | Brewer |Maryland :
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Andover | Billerica | Boston | Cambridge | Devens | Lexington | Massachusetts | Medford and Somerville | Rockland |Michigan :
Detroit | Houghton Lake | Macomb | Southfield |Minnesota :
Duluth | Eden Prairie | Fridley | Hibbing | Maple Grove | Minneapolis and St. Paul, Minnesota. | Minnetonka | St.Paul |Missouri :
Fulton | Milan | St. Louis |Nebraska :
Hebron | Nebraska City |Nevada :
Las Vegas | Tonopah | Tonopsh | Virginia |New Hampshire :
Lebanon | Macon | Manchester |New Jersey :
Basking Ridge | Bloomfield | Branchburg Township | Bridgewater | Brunswick | Burlington | Charlotte | Clark | Cranbury | Dunellen | East Brunswick | Edison | Fairfield | Far Hills | Flemington | Hackensack | Hopewell | Indianapolis | Jersey City | Linden | Livingston | Lyndhurst | Mahwah | Monmouth Junction | Montville | Mount Arlington | New Brunswick | Newark | Nutley | Paramus | Parsippany | Passaic | Paterson | Peapack-Gladstone | Pine Brook | Piscataway Township | Plainsboro | Princeton Junction | Rahway | Raritan | Somerset | Somerville | South Plainfield | Sparta | Summit | Titusville | Trenton | Warren Grove | West Orange | Westfield | Wharton | Whippany |New Mexico :
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New Hampshire |Ohio :
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Berlin |Germany :
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Bavaria |North Rhine Westphalia :
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Budapest |Istanbul :
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Basel | Zurich |Carlow :
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Brinny | Ringaskiddy |County Dublin :
Swords |Dún Laoghaire :
Dún Laoghaire |Meath :
Dunboyne |Republic of Ireland :
Cork | Dublin | Limerick | Waterford |Tipperary :
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Donegal |China :
China | Quarry Bay |Hubei :
Wuhan |Liaoning :
Dalian |Republic of China :
Beijing |Shanghai Sai :
Shanghai Shi |Tokiyo :
Osaka | Tokyo |Zhejiang :
Hangzhou |Melbourne :
South Yarra |New South Wales :
Ballina | Sydney |Queensland :
Queensland |Remote Australia :
Remote Australia |Republic of Western Australia :
Nedlands |Capital of Netherland :
Amsterdam |Netherlands :
Netherlands |Noord Holland :
Haarlem |North Brabant :
Breda |South Holland :
Leiden |North Yorkshire :
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Sheffield |United Kingdom :
England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |Buenos Aires :
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Austria |Vienna :
Vienna |Antwerp :
Heist op den Berg |Brussels :
Brussels |Flemish Brabant :
Zaventem |Bosnia and Herzegovina :
Sarajevo |Sofia City :
Sofia |Canada :
Canada |Ontario :
North York | Richmond Hill | Mississauga | Uxbridge | Renfrew |Quebec :
Montreal |Chile :
Santiago |Republic of Colombia :
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Croatia |Zagreb :
Zagreb |Bohemia :
Prague |Republic of Egypt :
Cairo |Estonia :
Tartu | Estonia |Harju County (Maakond) :
Tallinn |Chuuk :
North Ostrobothnia :
Oulu |Southwest Finland (Varsinais-Suomi) :
Turku |France :
Paris | Lyon |Attica :
Athens | Koropi |Greece :
Greece |East Java :
Surabaya |Jakarta :
Jakarta |Israel :
Netanya | Yavne | Be'Er Sheva | Kfar Saba | Tel Aviv |Italy :
Italy |Lombardy :
Rho |Japan :
Japan | Saitama |Tokyo :
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Almaty |Remote Korea :
Remote Korea |Republic of Korea :
Seoul |Kuala Lumpur :
Kuala Lumpur |Mexico :
Ciudad de México |North Island :
Auckland |Lima Region :
Lima |Cebu Province :
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Manila |Mazovia :
Warsaw |Remote :
Switzerland | Remote, USA | Remote - Middle East | Melbourne | Remote - Africa | Remote - Europe | Remote | Remote - South America (Latin Americal) | Lenexa | McFarland | Victoria |Bucharest :
Bucharest |Makkah :
Najran | King Abdullah Economic City | Jeddah | Riyadh | Khulais | Rabigh |Nišava District :
Niš |Singapore :
Singapore |South Africa :
Midrand | South Africa |Brazil :
Sao paulo | Brazil |South America :
Peru | Argentina |Catalonia :
Barcelona |Madrid :
Madrid |Sweden :
Sweden |Taipei :
Taipei |Williamson :
Brentwood |Republic of Thailand :
Bangkok |Kyiv Oblast :
Kyiv |Dubai :
Dubai |Hà Nội :
Hanoi | Hà Nội |Ho Chi Minh :
Ho Chi Minh City |