Specialist, Local Regulatory and PV network
About the role
Location: Afghanistan, Albania, Algeria, American Samoa, Andorra, Angola, Anguilla, Antarctica, Antigua and Barbuda, Argentina, Armenia, Aruba, Australia, Austria, Azerbaijan, Bahamas, Bahrain, Bangladesh, Barbados, Belarus, Belgium, Belize, Benin, Bermuda, Bhutan, Bolivia, Bonaire, Sint Eustatius and Saba, Bosnia and Herzegovina, Botswana, Bouvet Island, Brazil, British Indian Ocean Territory, Brunei Darussalam, Bulgaria, Burkina Faso, Burundi, Cabo Verde, Cambodia, Cameroon, Canada, Cayman Islands, Central African Republic, Chad, Chile, China, Christmas Island, Cocos (Keeling) Islands, Colombia, Comoros, Congo, Congo, The Democratic Republic of the, Cook Islands, Costa Rica, Croatia, Cuba, Curaçao, Cyprus, Czechia, Côte d'Ivoire, Denmark, Djibouti, Dominica, Dominican Republic, Ecuador, Egypt, El Salvador, Equatorial Guinea, Eritrea, Estonia, Eswatini, Ethiopia, Falkland Islands (Malvinas), Faroe Islands, Fiji, Finland, France, French Guiana, French Polynesia, French Southern Territories, Gabon, Gambia, Georgia, Germany, Ghana, Gibraltar, Greece, Greenland, Grenada, Guadeloupe, Guam, Guatemala, Guernsey, Guinea, Guinea-Bissau, Guyana, Haiti, Heard Island and McDonald Islands, Holy See (Vatican City State), Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Isle of Man, Israel, Italy, Jamaica, Japan, Jersey, Jordan, Kazakhstan, Kenya, Kiribati, Kosovo, Kuwait, Kyrgyzstan, Lao People's Democratic Republic, Latvia, Lebanon, Lesotho, Liberia, Libya, Liechtenstein, Lithuania, Luxembourg, Macao, Madagascar, Malawi, Malaysia, Maldives, Mali, Malta, Marshall Islands, Martinique, Mauritania, Mauritius, Mayotte, Mexico, Micronesia, Federated States of, Moldova, Monaco, Mongolia, Montenegro, Montserrat, Morocco, Mozambique, Myanmar, Namibia, Nauru, Nepal, Netherlands, New Caledonia, New Zealand, Nicaragua, Niger, Nigeria, Niue, Norfolk Island, North Macedonia, Northern Mariana Islands, Norway, Oman, Pakistan, Palau, Palestine, State of, Panama, Papua New Guinea, Paraguay, Peru, Philippines, Pitcairn, Poland, Portugal, Puerto Rico, Qatar, Romania, Russian Federation, Rwanda, Réunion, Saint Barthélemy, Saint Helena, Ascension and Tristan da Cunha, Saint Kitts and Nevis, Saint Lucia, Saint Martin (French part), Saint Pierre and Miquelon, Saint Vincent and the Grenadines, Samoa, San Marino, Sao Tome and Principe, Saudi Arabia, Senegal, Serbia, Seychelles, Sierra Leone, Singapore, Sint Maarten (Dutch part), Slovakia, Slovenia, Solomon Islands, Somalia, South Africa, South Georgia and the South Sandwich Islands, South Korea, South Sudan, Spain, Sri Lanka, Sudan, Suriname, Svalbard and Jan Mayen, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Tajikistan, Tanzania, Thailand, Timor-Leste, Togo, Tokelau, Tonga, Trinidad and Tobago, Tunisia, Turkey, Turkmenistan, Turks and Caicos Islands, Tuvalu, Uganda, Ukraine, United Arab Emirates, United Kingdom, United States, United States Minor Outlying Islands, Uruguay, Uzbekistan, Vanuatu, Venezuela, Vietnam, Virgin Islands, British, Virgin Islands, U.S., Wallis and Futuna, Western Sahara, Yemen, Zambia, Zimbabwe, Åland Islands The RA & PV specialist will act as Local Country Person Responsible for Pharmacovigilance and Regulatory Affairs (LCPPV/LCPRA) and serves as the primary local RA&PV representative to ensure compliance with national pharmacovigilance and regulatory requirements in Australia. This position is responsible for executing PV and RA activities at the local level, supporting the Marketing Authorisation Holder (MAH) in maintaining product compliance throughout its lifecycle. Main responsibilities • Prompt and effective communication with MAH and local regulatory authorities as required • Primary contact person with local regulatory authorities for Regulatory Affairs and Pharmacovigilance as per local requirements • Provision of local regulatory intelligence screening and expert advice for the responsible region(s) • Collection and reporting of locally suspected ADRs or ICSRs (FUs, translations) • Local management / oversight of risk minimization measures related to urgent safety restrictions and emerging safety issues • Support with development and implementation of local pharmacovigilance system in compliance with Global MAH's system and local regulations • Perform local non-indexed literature screening and screening of regulatory authority website/s for potential Adverse Drug Re