{"id":253585,"url":"https://alion.io/job/orca-bio-directorhead-pharmacovigilance","title":"Director/Head, Pharmacovigilance","company":{"id":4299,"name":"Orca Bio","domain":"orcabio.com","url":"https://alion.io/company/orca-bio","size_band":"501-1000","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Lever","truth_index":{"grade":"A","score":90,"open_postings":11,"ghost_share":0,"stale_share":0.182,"repost_share":0,"time_to_fill_p50_days":90,"computed_at":"2026-11-06T05:58:05Z"}},"role":"Biotech","role_family":"Biotech","seniority":"head","employment_type":"full_time","work_mode":"remote","remote_scope":"stated_countries","remote_scope_basis":"board_field","remote_working_hours":null,"hiring_geo_confidence":"structured","locations":[],"countries":[],"hiring_countries":["US"],"hiring_countries_total":1,"salary":{"min":200000,"max":245000,"currency":"USD","period":"year","gross":null,"usd_annual":245000},"salary_estimate":null,"experience_years_min":10,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[],"status":"live","first_seen_at":"2026-09-04T23:31:56Z","employer_posted_date":"2026-09-04","last_verified_at":"2026-11-06T06:49:51Z","board_verified":true,"closed_at":null,"days_open":62,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":62},"description":"Position Summary: Reporting to our Chief Development Officer, the Director/Head of Pharmacovigilance will lead and develop the safety function, providing direct guidance to a small, dedicated team while driving end-to-end operational oversight.\nKey Responsibilities\nLead risk management and mitigation activities for assigned products, leading safety data review and analysis for all products.\nResponsible for providing safety-related content for all clinical and regulatory documents.\nLead inspection preparedness efforts for pharmacovigilance and represent Orca’s pharmacovigilance organization at regulatory inspections.\nStay abreast of changes in regulations, leading updates to SOPs and other documentation to address any process gaps.\nIdentify and address resource and infrastructure needs, contribute to departmental budgets and planning to align with Orca products’ stage of development.\nRepresent product safety in the cross-functional team environment.\nLead safety governance activities in collaboration with medical monitors and leadership.\nLead safety related activities for regulatory filings including development of meeting request and briefing book content, SAP and TFL review, signal detection and risk identification, responses to regulatory queries, RMPs, REMs, ISS strategy, and regional safety related labeling activities.\nProvide guidance and mentorship to all direct reports within the pharmacovigilance function, including support and oversight of operations.\nQualifications\nMD Required\n10+ years of experience in drug safety, safety science and risk management at a pharmaceutical, biotech, or CRO, including people leadership experience.\nKnowledge of US and EU safety regulations pre and post marketing pharmacovigilance requirements.\nExperience with pharmacovigilance risk management, preferably at a commercial-stage company.\nProficiency in preparing pre-marketing and post marketing safety regulatory documents, including PSURs, PBRERs, PADER, and Risk Management Plans.\nExperience with clinical development, risk/benefit analysis, and safety assessment.\nStrong clinical, analytical, problem-solving, scientific writing, and communication skills.\nPrior experience working on a BLA/NDA. Prior experience leading risk management activities for a BLA/NDA preferred.\nHands-on mentality, ability to operate in a small biotech environment.\nKnowledge of cell therapy, bone marrow transplant or hematology oncology is a plus.\nExpertise in analyzing safety data from clinical and safety databases.\nExperience in MedDRA coding and search strategies.\nExcellent independent judgment based on knowledge and expertise.\nStrong personal time management and project management skills.","description_format":"text","description_chars":2696,"description_truncated":false,"requirements":{"experience_years_min":10,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":null,"security_clearance":false,"languages":[]},"benefits":[],"hiring_locations":[{"name":"United States","iso":"US","kind":"country"}],"hiring_excludes":[],"relocation_offered":false,"industries":["Clinical Trial Services (CRO)","Cell & Gene Therapy","Oncology Therapeutics"],"lifecycle":[{"event":"open","at":"2026-09-05T11:13:36Z"}],"visa":[],"liveness":{"score":59,"band":"ok","label":"Likely open","p_open":1,"p_active":0.821,"p_room":0.72,"age_days":62,"expected_fill_days":90,"reasons":["conf:3","win:mid","crowd:"],"computed_at":"2026-11-06T05:58:05Z"},"pay":{"stated_usd_annual":245000,"is_top_pay":false},"html_url":"https://alion.io/job/orca-bio-directorhead-pharmacovigilance","json_url":"https://alion.io/job/orca-bio-directorhead-pharmacovigilance.json","meta":{"generated_at":"2026-11-06T07:26:59Z","cache_seconds":300,"methodology":"https://alion.io/methodology","terms":"https://alion.io/terms","contact":"https://alion.io/contact","api":"https://alion.io/developers","about":"Alion is a live layer of people, companies and AI agents: who they are, whether they are real and active right now, what they do and how to work with them, readable by people and by agents and paid per call.","catalog":"https://alion.io/catalog.json","usage":{"tier":"crawler_verified","counted_by":"address","units_charged":1,"used_today":13245,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-11-07T00:00:00Z"}},"offers":[{"id":"company.slices","title":"One company in depth, by slice","status":"live","price":{"credits":0.02,"usd":0.002,"plus_per_slice":{"credits":0.05,"usd":0.005}},"unit":"per company, plus each slice with data","note":"the employer in depth","call":{"mcp_tool":"get_company","arguments":{"id":4299},"rest":"https://alion.io/mcp/rest/get_company?id=4299"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Forca-bio-directorhead-pharmacovigilance"},{"id":"market.stats","title":"A market slice: pay, demand and time to fill","status":"live","price":{"credits":1,"usd":0.1},"unit":"per slice","note":"pay, demand and time to fill for this role and place","call":{"mcp_tool":"market_stats"},"human":"https://alion.io/catalog?offer=market.stats&for=job%2Forca-bio-directorhead-pharmacovigilance"},{"id":"job.search","title":"Open jobs by role, technology, place, pay and visa","status":"live","price":{"credits":0.02,"usd":0.002},"unit":"per posting in a list","note":"similar open postings","call":{"mcp_tool":"search_jobs"},"human":"https://alion.io/catalog?offer=job.search&for=job%2Forca-bio-directorhead-pharmacovigilance"},{"id":"company.verify","title":"Is this company real and active right now","status":"pilot","price":null,"unit":"per company","request":{"url":"https://alion.io/catalog/request","method":"POST","body":"{\"offer\": \"company.verify\", \"for\": \"job/orca-bio-directorhead-pharmacovigilance\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Forca-bio-directorhead-pharmacovigilance"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":253585}},{"tool":"search_jobs","arguments":{"company":"orcabio.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":253585},"note":"people open to offers who fit this vacancy"}],"note":"The same data through MCP tools: https://alion.io/mcp/open needs no sign-in (compact searches, postings, people); https://alion.io/mcp with an Alion account has everything. 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