Job Title: Director, Pharmacovigilance Safety Physician
Location: Bucharest, Romania
Company: Teva Pharmaceuticals
Job ID: 56387
Date: Nov 28, 2024
About Teva Pharmaceuticals
Teva is the world's largest producer of generic medicines and a global leader in the pharmaceutical industry. We are committed to improving global health by providing access to quality, affordable medicines. Our diverse portfolio serves 200 million people every day, and we are actively investing in research, development, and innovation to improve health outcomes. We continue to grow in both the generic and specialty medicines sectors and are dedicated to delivering patient-centered solutions.
The Opportunity
Teva is seeking a Director, Pharmacovigilance Safety Physician to lead the safety activities for assigned products throughout their lifecycle. The role will be responsible for monitoring, mitigating risks, and providing comprehensive safety information to patients, prescribers, and regulators.
Key Responsibilities
Safety Profile Management:
Lead the medical evaluation of safety data for assigned and non-assigned products, including signal detection, dose escalation evaluations, and preparation of regulatory safety reports (e.g., PSUR, PADER, DSUR).
Review complex Health Hazard Assessments and respond to Health Authority requests.
Signal Management:
Perform signal validation, author complex signal evaluations, and manage signal evaluation activities.
Assess causality, consolidate safety data, and determine if a signal qualifies as a risk.
Risk Management:
Contribute to the development of Risk Management Plans (RMPs), Risk Evaluation and Mitigation Strategies (REMS), and additional risk minimization measures throughout the product lifecycle.
Define important risks, potential risks, and missing information for assigned products.
Cross-Functional Collaboration:
Represent Pharmacovigilance in the Product Label Working Group, ensuring safety-related sections of the product label are properly evaluated and negotiated with regulatory agencies.
Collaborate with internal (e.g., Medical Affairs, Clinical Development, Quality) and external stakeholders (e.g., KOLs, CROs) to communicate the safety profile of products and ensure the effective execution of safety strategies.
Health Authority Submissions:
Provide safety contributions for Health Authority submissions and responses.
Represent pharmacovigilance during due diligence activities for potential products.
Qualifications and Experience
Medical Doctor degree or equivalent.
Clinical practice experience and/or epidemiological training.
A minimum of 5 years’ experience in pharmacovigilance and drug safety, particularly as a safety physician.
Proven ability to handle safety surveillance tasks, chair safety committee meetings, and serve as a subject matter expert.
Strong communication skills with the ability to collaborate with various departments and influence others without direct authority.
Ability to work within a matrix team, across multiple time zones.
Fluency in English (both oral and written).
Reports To
Sr Dir, Pharmacovigilance
Teva’s Equal Employment Opportunity Commitment
Teva Pharmaceuticals is an equal opportunity employer, committed to diversity and inclusion in the workplace. We provide equal employment opportunities regardless of age, race, creed, religion, sex, disability, or any other legally protected status. If you require accommodations during the recruitment process, please let us know.
Andra Pradesh :
Anantapur | Bhimavaram | Chittoor | Guntur | Gurgaon | Mangalagiri | Pydibimavaram | Tirupathi | Visakhapatnam |Assam :
Dibrugarh | Diburghar | Guwahati |Bihar :
Hajipur | Patna |Chhattisgarh :
Bilaspur | Eot Municipality | Raipur |Delhi :
Delhi | India | New Delhi | PAN-India |Goa :
Goa | Panaji |Gujarat :
Ahmedabad | Baroda | Gandhinagar | Mehsana | Tarasadi | Vadodara | Vapi |Haryana :
Ambala | Gurugram | Haryana | Hisar | Kurukshetra | Panchkula | Rohtak |Himachal Pradesh :
Solan |India :
Siliguri |Jharkhand :
Ranchi |Karnataka :
B.G Nagara | Bangalore | Belgaum | Bengaluru | Bommasandra | Mangaluru | Mysore | Udupi |Kerala :
Kannur | Kochi | Malappuram | Thiruvananthapuram |Madhya Pradesh :
Dewas | Gwalior | Indore | Khandwa | Khargone | Ujjain |Maharashtra :
Ambernath | Amravati | Aurangabad | Dhule | Jalgaon | Kolhapur | Mumbai | Nagpur | Nashik | Navi Mumbai | Pune | Pune city | Shirpur | Tarapur | Thane | Vikhroli |PAN-India :
Panjab :
Punjab :
Bathinda | Bela | Chandigarh | Moga | Mohali | Patiala | Phagwara | Rajpura |Rajasthan :
Banasthali | Jaipur | Pilani | Udaipur |Sikkim :
Rangpo |Tamil Nadu :
Annamalainagar | Chennai | Coimbatore | Erode | Madurai | Nagercoil | Ooty | Srivilliputtur | Tiruchirappalli | Trichy |Uttar Pradesh :
Gajraula | Gautam buddha Nagar | Ghaziabad | Greater Noida | Jhansi | Lucknow | Mathura | Noida | Park City | Prayagraj | Varanasi |Uttarakhand :
Dehradun | Nainital | Rishikesh |West Bengal :
Kolkata | Mukundapur |Alabama :
Birmingham |Alaska :
Anchorage | Barrow | Bethel | Juneau | Sitka | Wrangell |Arizona :
Chandler | Kingman | Lake Havasu City | Peridot | Phoenix | Tempe | Tucson | Yuma |Arkansas :
Fort Smith |California :
Alameda | Brisbane | California | Crescent City | Davis | El Monte | El Segundo | Emeryville | Eureka | Fortuna | Foster City | Fremont | Glendale | Irvine | La Jolla | Los Angeles | Martinez | Menlo Park | Mountain View | Nevada | Oakland | Pacheco | Palo Alto | Pasadena | Pleasanton | Redding | Redwood City | Riverside | Sacramento | San Bernardino | San Diego | San Francisco | San Gabriel | San Jose | Santa Clara | Santa Cruz | Santa Monica | Simi Valley | Soledad | South San Francisco | Stanford | Stanton | Vallejo | West Valley City | Whittier | Willits |Colorado :
Denver |Connecticut :
Bridgeport | Bristol | Enfield | Groton | Newtown | South Windsor | Storrs | West Hartford |D.C :
Washington |Delaware :
Wilmington |Florida :
Boca Raton | Clearwater | Coral Gables | Coral Springs | Daytona Beach | Gainesville | Jacksonville | Miami | Naples | Orlando | Pembroke Pines | Port St. Lucie | Rueil-Malmaison | Stuart | Tallahassee | Tampa | West Palm Beach |Georgia :
Atlanta | Rome |Hawaii :
Honolulu |Idaho :
Boise |Illinois :
Abbott Park | Champaign | Chicago | Deerfield | Lake Forest | Lombard | Naperville | Norridge | Park RIdge | Round Lake |Indiana :
Bloomington | West Lafayette |Kansas :
Garden city | Lawrence |Kenlucky :
Shelbyville |Kington :
Frank Scottile Blvd |LA :
Baton Rouge | Monroe | New Orleans |Louisiana :
Lake Charles | Shreveport |Maine :
Bangor | Brewer |Maryland :
Aberdeen | Baltimore | Bel Air | Cheverly | Elkridge | Gaithersburg | Largo | Linthicum | Rockville | Towson | Upper Marlboro |Massachusetts :
Andover | Billerica | Boston | Cambridge | Devens | Lexington | Massachusetts | Medford and Somerville | Rockland |Michigan :
Detroit | Houghton Lake |Minnesota :
Duluth | Eden Prairie | Hibbing | Minneapolis and St. Paul, Minnesota. | St.Paul |Missouri :
Fulton | Milan | St. Louis |Nebraska :
Hebron | Nebraska City |Nevada :
Las Vegas |New Hampshire :
Lebanon | Manchester |New Jersey :
Basking Ridge | Bloomfield | Branchburg Township | Bridgewater | Brunswick | Burlington | Charlotte | Clark | Cranbury | Dunellen | East Brunswick | Edison | Fairfield | Far Hills | Flemington | Hackensack | Indianapolis | Jersey City | Linden | Livingston | Lyndhurst | Mahwah | Monmouth Junction | 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 :
Farmington | Santa Fe | Tucumcari |New York :
Albany | Biddle | Buffalo | Hawthorne | Hicksville | Ithaca | Middleburgh | Morningside Heights | New York | Rensselaer | Syracuse | Utica |North Carolina :
Concord | Lumberton | North Carolina |North Caroline :
Carolina Beach | Chapel Hills | Durham | Holly Springs | Morrisville | Philippines | Raleigh | Sanford | Scottsdale |North Dakota :
Dickinson |northeastern :
New Hampshire |Ohio :
Cincinnati | Cleveland | Columbus, | Macedonia | oxford |Oklahoma :
Oklahoma City |Oregon :
Bend | Coquille | Corvallis | Eugene | Portland | Roseburg | Salem | Springfield |Pennsylvania :
Ambler | Collegeville | Harrisburg | Lancaster | Middletown | Philadelphia | Pittsburgh | Plymouth Meeting | Radnor | West Chester | Wyomissing |Portugal :
Lisbon | Portugal |Puerto Rico :
San Juan |Republic of Mexico :
Mexico |South Carolina :
Charleston |Tennessee :
Nashville |Texas :
Abilene | Austin | Bulverde | Corsicana | Dallas | Houston | Lakeway | Longview | Plano | Richardson | San Antonio | Tyler | Waco |United states :
fairmont | Georgia | United States |United States :
Hawai | Sylmar |Virginia :
Blacksburg | Charlottesville | Falls Church |Washington :
Bothell | Goldendale | Mount Vernon | Pullman | Seattle | Sherwood |WI :
Madison | Wausau |Wisconsin :
Portage |Wyoming :
Cokeville |Baden-Wurttemberg :
Freiburg | Grenzach | Heidelberg | Karlsruhe | Konstanz | Stuttgart | Tubingen | Ulm |Bavaria :
Bayreuth | Erlangen | Munich | Regensburg | Wurzburg |Berlin :
Mitte |Brandenburg :
Berlin |Germany :
Germany | GErmany |Hesse :
Marburg |Hessen :
Frankfurt |Lower Saxony :
Gottingen | Hannover | Leipzig |Mecklenburg Vorpommern :
Rostock |Munich :
Bavaria |North Rhine Westphalia :
Aachen | Bielefeld | Bochum | Bonn | Cologne | Dortmund | Duisburg | Dusseldorf | Munster |Rhineland Palatinate :
Mainz |Rotherbaum :
Hamburg |Saarland :
Saarbrucken |Saxony Anhalt :
Halle |Schleswig Holstein :
Kiel |BULGARIA :
Bulgaria |Denmark :
Copenhagen | Denmark |Europe :
Latvia | Leuven | Poland | Spain |Finland :
Finland |Hungary :
Budapest |Istanbul :
Istanbul | Turkey |Norway :
Norway | NOrway |Romania :
Romania |Serbia :
Belgrade | Serbia |Switzerland :
Basel | Zurich |China :
China |Hubei :
Wuhan |Republic of China :
Beijing |Shanghai Sai :
Shanghai Shi |Tokiyo :
Osaka | Tokyo |Zhejiang :
Hangzhou |New South Wales :
Ballina | Sydney |Queensland :
Queensland |Remote Australia :
Remote Australia |Republic of Western Australia :
Nedlands |Cork :
Ringaskiddy |County Dublin :
Swords |Dún Laoghaire :
Dún Laoghaire |Republic of Ireland :
Dublin | Limerick | Waterford |Buenos Aires :
Buenos Aires |Austria :
Austria |Vienna :
Vienna |Antwerp :
Heist op den Berg |Brussels :
Brussels |Sofia City :
Sofia |Canada :
Canada |Ontario :
Uxbridge | North York | Richmond Hill |Quebec :
Montreal |Chile :
Santiago |Republic of Colombia :
Bogota |Croatia :
Croatia |Zagreb :
Zagreb |Bohemia :
Prague |Republic of Egypt :
Cairo |South Yorkshire :
Sheffield |United Kingdom :
Harlow | Stirling | London | United Kingdom | Maidenhead | Leeds | Salt Lake City |Estonia :
Tartu | Estonia |Harju County (Maakond) :
Tallinn |Chuuk :
North Ostrobothnia :
Oulu |Southwest Finland (Varsinais-Suomi) :
Turku |France :
Lyon | Paris |Greece :
Greece |East Java :
Surabaya |Jakarta :
Jakarta |Israel :
Tel Aviv | Netanya | Be'Er Sheva | Kfar Saba |Italy :
Italy |Lombardy :
Rho |Tokyo :
Otemachi |Kazakhstan :
Almaty |Remote Korea :
Remote Korea |Republic of Korea :
Seoul |Mexico :
Ciudad de México |Capital of Netherland :
Amsterdam |Netherlands :
Netherlands |Noord Holland :
Haarlem |Cebu Province :
Cebu City |Philippines :
Manila |Mazovia :
Warsaw |Remote :
Remote - Europe | Switzerland | Remote, USA | Remote |Bucharest :
Bucharest |Makkah :
Jeddah | Khulais | Rabigh | Riyadh | Najran |Singapore :
Singapore |South Africa :
Midrand |Brazil :
Sao paulo |South America :
Argentina |Catalonia :
Barcelona |Madrid :
Madrid |Sweden :
Sweden |Taipei :
Taipei |Williamson :
Brentwood |Republic of Thailand :
Bangkok |Dubai :
Dubai |Antrim :
Larne |Cheshire :
Runcorn |